{"id":19042,"date":"2020-01-07T14:41:41","date_gmt":"2020-01-07T13:41:41","guid":{"rendered":"https:\/\/www.blackbirdee.fr\/prod\/ALISPHARM\/?page_id=19042"},"modified":"2022-03-24T14:23:08","modified_gmt":"2022-03-24T13:23:08","slug":"our-services","status":"publish","type":"page","link":"https:\/\/www.blackbirdee.fr\/prod\/ALISPHARM\/our-services\/","title":{"rendered":"Our Services"},"content":{"rendered":"

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OUR SERVICES<\/span><\/h1>

For each service:<\/span>
\nOperational stakeholders and a team of experts dedicated to the project.<\/span><\/span><\/h2>
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Pharmaceuticals & Biotechs<\/span><\/a><\/div>
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Medical Devices<\/span><\/a><\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=\u00a0\u00bb1\/3″][\/vc_column][\/vc_row][vc_row heading_color=\u00a0\u00bblight\u00a0\u00bb section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbimage\u00a0\u00bb bg_image=\u00a0\u00bb19332″ bg_image_type=\u00a0\u00bbhorizontal-parallax-lr\u00a0\u00bb bg_image_size=\u00a0\u00bbfull\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb2x\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb6x\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb separator_bottom=\u00a0\u00bbtriangle-separator\u00a0\u00bb separator_bottom_size=\u00a0\u00bb60px\u00a0\u00bb font_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column width=\u00a0\u00bb1\/6″][\/vc_column][vc_column width=\u00a0\u00bb1\/2″ css=\u00a0\u00bb.vc_custom_1574759425560{padding-right: 5% !important;padding-left: 8% !important;}\u00a0\u00bb]
OUR SERVICES<\/span><\/span><\/div>
For each service:<\/span>
\nOperational stakeholders and a team of experts dedicated to the project.<\/span><\/span><\/div>
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Pharmaceuticals & Biotechs<\/span><\/a><\/div>
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Medical Devices<\/span><\/a><\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=\u00a0\u00bb1\/3″][\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb mobile_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb section_id=\u00a0\u00bbpharma1″][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb css=\u00a0\u00bb.vc_custom_1574693840583{margin-right: 5% !important;margin-left: 9% !important;}\u00a0\u00bb]
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PHARMACEUTICALS & BIOTECHS<\/span><\/h3>
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PHARMACEUTICALS & BIOTECHS<\/span><\/h3>
<\/div>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb mobile_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb width=\u00a0\u00bb1\/2″][vc_single_image image=\u00a0\u00bb19338″ img_size=\u00a0\u00bb\u00a0\u00bb][\/vc_column][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb width=\u00a0\u00bb1\/2″ css=\u00a0\u00bb.vc_custom_1574689001450{padding-right: 8% !important;padding-left: 12% !important;}\u00a0\u00bb]

AlisPharm<\/span> supports the pharmaceutical and biotechnology industries in the development of their products and processes, with a solid quality and regulatory expertise \u00abTo do it Right the First time\u00bb<\/span>.<\/span><\/span><\/h4>
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AlisPharm<\/span> supports the pharmaceutical and biotechnology industries in the development of their products and processes, with a solid quality and regulatory expertise \u00abTo do it Right the First time\u00bb<\/span>.<\/span><\/span><\/h4>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column width=\u00a0\u00bb1\/2″ css=\u00a0\u00bb.vc_custom_1574682461478{padding-right: 8% !important;padding-left: 8% !important;}\u00a0\u00bb]

AlisPharm<\/span> supports the pharmaceutical and biotechnology industries in the development of their products and processes, with a solid quality and regulatory expertise \u00abTo do it Right the First time\u00bb<\/span>.<\/span><\/span><\/h4>
<\/div>[\/vc_column][vc_column width=\u00a0\u00bb1\/2″][vc_single_image image=\u00a0\u00bb19338″ img_size=\u00a0\u00bb\u00a0\u00bb][\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-6x\u00a0\u00bb width=\u00a0\u00bb1\/3″][\/vc_column][vc_column column_effect=\u00a0\u00bbvertical-parallax\u00a0\u00bb column_effect_limit=\u00a0\u00bb5x\u00a0\u00bb column_effect_invert=\u00a0\u00bbtrue\u00a0\u00bb column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-6x\u00a0\u00bb width=\u00a0\u00bb1\/5″ tablet_sm_width=\u00a0\u00bbhide\u00a0\u00bb mobile_width=\u00a0\u00bbhide\u00a0\u00bb css=\u00a0\u00bb.vc_custom_1574430692011{padding-right: 10% !important;padding-left: 10% !important;background-color: #00bbff !important;}\u00a0\u00bb]
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01 <\/span>OPERATIONAL QUALITY ASSURANCE<\/span>
\n02 <\/span>QUALITY MANAGEMENT SYSTEM<\/span>
\n03 <\/span>INDUSTRIAL TRANSFER
\n<\/span>04 <\/span>COMMISSIONING & ENGINEERING<\/span>
\n05 <\/span>VALIDATION OF COMPUTERIZED SYSTEMS<\/span>
\n06 <\/span>VALIDATION OF AUTOMATED SYSTEMS<\/span>
\n07 <\/span>QUALITY CONTROL<\/span>
\n08 <\/span>REGULATORY AFFAIRS<\/span>
\n09 <\/span>PHARMACOVIGILANCE & CLINIC<\/span>
\n10 <\/span>PROCESS VALIDATION
\n<\/span>11 <\/span>EQUIPMENT QUALIFICATION<\/span><\/span><\/span><\/h4>
<\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-3x\u00a0\u00bb width=\u00a0\u00bb1\/2″ clipping_animation=\u00a0\u00bbclipping-up\u00a0\u00bb el_wrapper_class=\u00a0\u00bbblocRollPharmaPrestations\u00a0\u00bb][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702793319{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma1″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
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OPERATIONNAL QUALITY ASSURANCE<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Processing Quality Events \/ NC \/ CAPA \/ Change Control<\/span><\/span><\/h5>
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\u2022 <\/span>Coordinating quality action plans<\/span><\/span><\/h5>
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\u2022 <\/span>Quality management with suppliers, production and laboratories<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702800973{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma2″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
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QUALITY MANAGEMENT SYSTEM<\/span><\/span><\/h4>
<\/span><\/div>
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\u2022 <\/span>Creating and reviewing the QMS according to the BPF\/GMP<\/span><\/span><\/h5>
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\u2022 <\/span>Preparing audits and managing post-audit answers<\/span><\/span><\/h5>
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\u2022 <\/span>Training, awareness and supporting staff in the quality process<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702810108{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma3″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
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INDUSTRIAL TRANSFER<\/span><\/span><\/h4>
<\/span><\/div>
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\u2022 <\/span>Management of inter- and intra-site transfers (complete lines or equipment relocation)<\/span><\/span><\/h5>
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\u2022 <\/span>Scale up, scale down<\/span><\/span><\/h5>
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\u2022 <\/span>Analytical transfer, technological transfer<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702818685{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma4″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
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COMMISSIONING & ENGINEERING<\/span><\/span><\/h4>
<\/span><\/div>
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\u2022 <\/span>User needs, drafting the requirements specifications, defining the specifications<\/span><\/span><\/h5>
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\u2022 <\/span>Purchase and installation of equipment, automated systems, utilities, premises<\/span><\/span><\/h5>
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\u2022 <\/span>Suppliers, installation and testing management<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574892770723{padding-top: 7% !important;padding-right: 10% !important;padding-bottom: 7% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma5″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

VALIDATION OF COMPUTERIZED SYSTEMS<\/span><\/span><\/h4>
<\/span><\/div>
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\u2022 <\/span>Validation of computerized systems (GAMP5 environment, 21CFR part11)<\/span><\/span><\/h5>
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\u2022 <\/span>ERP, GED, automated and embedded systems<\/span><\/span><\/h5>
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\u2022 <\/span>Integration, software, unit and non-regression tests<\/span><\/span><\/h5>
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\u2022 <\/span>Data Integrity Projects (traceability, access, audit trail)<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702840629{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma6″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
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VALIDATION OF AUTOMATED SYSTEMS<\/span><\/span><\/h4>
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\u2022 <\/span>Production and Laboratory Systems (PLC, IHM) and SCADA Supervision<\/span><\/span><\/h5>
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\u2022 <\/span>Audit trail, access management, data saving, back-up, restore<\/span><\/span><\/h5>
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\u2022 <\/span>VMP, protocols, reports<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702849540{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma7″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
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QUALITY CONTROL<\/span><\/span><\/h4>
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\u2022 <\/span>Analytical and microbiological development and validation<\/span><\/span><\/h5>
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\u2022 <\/span>Analysis of test results, management of OOS<\/span><\/span><\/h5>
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\u2022 <\/span>Data integrity project, LIMS installation<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702859075{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma8″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
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REGULATORY AFFAIRS<\/span><\/span><\/h4>
<\/span><\/div>
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\u2022 <\/span>Marketing authorization applications (MAA) files<\/span><\/span><\/h5>
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\u2022 <\/span>Modules 2, 3, 4 and 5 (CTD and e-CTD format)<\/span><\/span><\/h5>
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\u2022 <\/span>Responses to health authorities of different countries<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702869643{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma9″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
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PHARMACOVIGILANCE & CLINIC<\/span><\/span><\/h4>
<\/span><\/div>
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\u2022 <\/span>Management of adverse events, adverse reaction (AR) reports<\/span><\/span><\/h5>
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\u2022 <\/span>Writing PV reports (PSURs)<\/span><\/span><\/h5>
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\u2022 <\/span>Product benefit\/risk management<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959967016{padding-top: 5% !important;padding-right: 10% !important;padding-bottom: 5% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma10″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

PROCESS VALIDATION<\/span><\/span><\/h4>
<\/span><\/div>
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\u2022 <\/span>Optimizing manufacturing and cleaning processes<\/span><\/span><\/h5>
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\u2022 <\/span>Experience plan, statistical process control tools<\/span><\/span><\/h5>
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\u2022 <\/span>Validation of manufacturing, cleaning, sterilization, packaging processes<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Strategies and worst cases (equipment, product) definition<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702888227{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma11″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

EQUIPMENT QUALIFICATION<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Laboratory and production equipment, utilities, premises<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>FAT, SAT, IQ, OQ, PQ<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>VMP, protocols, reports<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb el_class=\u00a0\u00bbblocDynamiquePrestations1″][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb width=\u00a0\u00bb1\/2″ el_wrapper_class=\u00a0\u00bbblocMenuPharmaPrestations\u00a0\u00bb]

01 <\/span>OPERATIONNAL QUALITY ASSURANCE<\/span>
\n02 <\/span>QUALITY MANAGEMENT SYSTEM<\/span>
\n03 <\/span>INDUSTRIAL TRANSFER
\n<\/span>04 <\/span>COMMISSIONING & ENGINEERING<\/span>
\n05 <\/span>VALIDATION OF COMPUTERIZED SYSTEMS<\/span>
\n06 <\/span>VALIDATION OF AUTOMATED SYSTEMS<\/span>
\n07 <\/span>QUALITY CONTROL<\/span>
\n08 <\/span>REGULATORY AFFAIRS<\/span>
\n09 <\/span>PHARMACOVIGILANCE & CLINIC<\/span>
\n10 <\/span>PROCESS VALIDATION
\n<\/span>11 <\/span>EQUIPMENT QUALIFICATION<\/span><\/span><\/span><\/h4>
<\/div>[\/vc_column][vc_column width=\u00a0\u00bb1\/2″ el_wrapper_class=\u00a0\u00bbblocRollPharmaPrestations\u00a0\u00bb][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960341286{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma1″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

OPERATIONNAL QUALITY ASSURANCE<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Processing Quality Events \/ NC \/ CAPA \/ Change Control<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Coordinating quality action plans<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Quality management with suppliers, production and laboratories<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960335232{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma2″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

QUALITY MANAGEMENT SYSTEM<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Creating and reviewing the QMS according to the BPF\/GMP<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Preparing audits and managing post-audit answers<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Training, awareness and supporting staff in the quality process<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960329408{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma3″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

INDUSTRIAL TRANSFER<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Management of inter- and intra-site transfers (complete lines or equipment relocation)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Scale up, scale down<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Analytical transfer, technological transfer<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960322868{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma4″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

COMMISSIONING & ENGINEERING<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>User needs, drafting the requirements specifications, defining the specifications<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Purchase and installation of equipment, automated systems, utilities, premises<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Suppliers, installation and testing management<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960314824{padding-top: 7% !important;padding-right: 10% !important;padding-bottom: 7% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma5″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

VALIDATION OF COMPUTERIZED SYSTEMS<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Validation of computerized systems (GAMP5 environment, 21CFR part11)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>ERP, GED, automated and embedded systems<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Integration, software, unit and non-regression tests<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Data Integrity Projects (traceability, access, audit trail)<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960296575{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma6″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

VALIDATION OF AUTOMATED SYSTEMS<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Production and Laboratory Systems (PLC, IHM) and SCADA Supervision<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Audit trail, access management, data saving, back-up, restore<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>VMP, protocols, reports<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960289983{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma7″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

QUALITY CONTROL<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Analytical and microbiological development and validation<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Analysis of test results, management of OOS<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Data integrity project, LIMS installation<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960283315{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma8″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

REGULATORY AFFAIRS<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Marketing authorization applications (MAA) files<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Modules 2, 3, 4 and 5 (CTD and e-CTD format)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Responses to health authorities of different countries<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960277475{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma9″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

PHARMACOVIGILANCE & CLINIC<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Management of adverse events, adverse reaction (AR) reports<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Writing PV reports (PSURs)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Product benefit\/risk management<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960269979{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma10″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

PROCESS VALIDATION<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Optimizing manufacturing and cleaning processes<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Experience plan, statistical process control tools<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Validation of manufacturing, cleaning, sterilization, packaging processes<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Strategies and worst cases (equipment, product) definition<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960263953{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma11″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

EQUIPMENT QUALIFICATION<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Laboratory and production equipment, utilities, premises<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>FAT, SAT, IQ, OQ, PQ<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>VMP, protocols, reports<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb css=\u00a0\u00bb.vc_custom_1574701962600{margin-right: 4% !important;margin-left: 5% !important;}\u00a0\u00bb]
<\/div>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb mobile_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb section_id=\u00a0\u00bbdispositifs1″][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb css=\u00a0\u00bb.vc_custom_1574701962600{margin-right: 4% !important;margin-left: 5% !important;}\u00a0\u00bb]
<\/div>

MEDICAL DEVICES<\/span><\/h3>
<\/div>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb section_id=\u00a0\u00bbdispositifs2″][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb css=\u00a0\u00bb.vc_custom_1574690555134{margin-right: 8% !important;margin-left: 8% !important;}\u00a0\u00bb]

MEDICAL DEVICES<\/span><\/h3>
<\/div>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb mobile_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb width=\u00a0\u00bb1\/2″ css=\u00a0\u00bb.vc_custom_1574689022532{padding-right: 12% !important;padding-left: 17% !important;}\u00a0\u00bb]

In a constantly evolving regulatory environment, AlisPharm<\/span> guides the medical devices manufacturer throughout its product lifecycle, to meet the expectations of health authorities and enable a reliable marketing launch.<\/span><\/span><\/span><\/h4>
<\/div>[\/vc_column][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb width=\u00a0\u00bb1\/2″][vc_single_image image=\u00a0\u00bb19339″ img_size=\u00a0\u00bb\u00a0\u00bb][\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb3x\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb mobile_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb width=\u00a0\u00bb1\/2″][vc_single_image image=\u00a0\u00bb19339″ img_size=\u00a0\u00bb\u00a0\u00bb][\/vc_column][vc_column width=\u00a0\u00bb1\/2″ css=\u00a0\u00bb.vc_custom_1574689819244{padding-right: 8% !important;padding-left: 12% !important;}\u00a0\u00bb]

In a constantly evolving regulatory environment, AlisPharm<\/span> guides the medical devices manufacturer throughout its product lifecycle, to meet the expectations of health authorities and enable a reliable marketing launch.<\/span><\/span><\/span><\/h4>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column width=\u00a0\u00bb1\/2″ css=\u00a0\u00bb.vc_custom_1574682461478{padding-right: 8% !important;padding-left: 8% !important;}\u00a0\u00bb]

In a constantly evolving regulatory environment, AlisPharm<\/span> guides the medical devices manufacturer throughout its product lifecycle, to meet the expectations of health authorities and enable a reliable marketing launch.<\/span><\/span><\/span><\/h4>
<\/div>[\/vc_column][vc_column width=\u00a0\u00bb1\/2″][vc_single_image image=\u00a0\u00bb19339″ img_size=\u00a0\u00bb\u00a0\u00bb][\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-6x\u00a0\u00bb width=\u00a0\u00bb2\/5″][\/vc_column][vc_column column_effect=\u00a0\u00bbvertical-parallax\u00a0\u00bb column_effect_limit=\u00a0\u00bb5x\u00a0\u00bb column_effect_invert=\u00a0\u00bbtrue\u00a0\u00bb column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-6x\u00a0\u00bb width=\u00a0\u00bb1\/3″ tablet_sm_width=\u00a0\u00bbhide\u00a0\u00bb mobile_width=\u00a0\u00bbhide\u00a0\u00bb css=\u00a0\u00bb.vc_custom_1575368627384{margin-right: 20% !important;margin-left: 20% !important;padding-right: 10% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb]
<\/div>[vc_single_image image=\u00a0\u00bb19345″ img_size=\u00a0\u00bb\u00a0\u00bb alignment=\u00a0\u00bbcenter\u00a0\u00bb el_class=\u00a0\u00bbIcoPrestations\u00a0\u00bb]
<\/div>[\/vc_column][vc_column width=\u00a0\u00bb1\/5″][\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb mobile_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb el_class=\u00a0\u00bbblocDynamiquePrestations2″][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-3x\u00a0\u00bb width=\u00a0\u00bb1\/2″ clipping_animation=\u00a0\u00bbclipping-up\u00a0\u00bb el_wrapper_class=\u00a0\u00bbblocRollDispositifsPrestations\u00a0\u00bb][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574892910627{padding-top: 7% !important;padding-right: 10% !important;padding-bottom: 7% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs1″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

REGULATORY AFFAIRS<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Writing and updating CE\/510k marking files<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Regulatory monitoring<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Provide answers to questions from notified bodies and health authorities<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Export submission (worldwide)<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959336719{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs2″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

RISK MANAGEMENT<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>AMDEC Methodology (pFMEA) on products and processes<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Defining the risk management plan and updating\/creating the RMF<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Benefits\/risks documents<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959412651{padding-top: 7% !important;padding-right: 10% !important;padding-bottom: 7% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs3″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

DESIGN TRANSFER<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Design input, output, verification and documents validation<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Writing and updating DMR\/DHF\/DHR<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Management of the exchanges between R&D and production<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Methods\/industrialization: setting up inspection plans<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959473494{padding-top: 6% !important;padding-right: 10% !important;padding-bottom: 6% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs4″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

QUALITY MANAGEMENT SYSTEM<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Creating and reviewing the QMS according to ISO 13485 (current version)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Preparing audits and managing post-audit answers<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Training, awareness, and supporting staff in the quality process<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959539042{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs5″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

SYSTEM ENGINEERING<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Management of electromedical systems (specifications, test plan, tests)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>V&V according IEC 62304, 60601 norms<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Writing technical and functional specifications, CDC, URS<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574893084915{padding-top: 13% !important;padding-right: 10% !important;padding-bottom: 13% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs6″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

AUDIT & CONSULTING<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Quality and regulatory audit<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Support the implementation of actions plan<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Change management support<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959697276{padding-top: 9% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs7″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

MEDICAL DEVICES REGULATION<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Monitoring customer sites to ensure their compliances with new regulations<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>PMS, UDI, clinic, reclassification of medical devices<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Change control management, implementation of changes<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959589130{padding-top: 9% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs8″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

CLINICAL & BIOLOGICAL EVALUATION<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Writing clinical and biological evaluation reports<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Data recovery (clinical studies or in vivo and in vitro trials data), bibliographic research<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Compliance with MEDDEV 2.7.1 rev4 and MDR<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574893173682{padding-top: 10% !important;padding-right: 10% !important;padding-bottom: 10% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs9″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

SPECIAL PROCESS VALIDATION<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Cleaning, conditioning of MDs, sterilization (ETO, gamma, autoclaves), laser marking and engraving, etc.<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Strategies, worst cases and sampling plans definition<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Trials management with subcontractors<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959748714{padding-top: 9% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs10″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

VALIDATION OF COMPUTERIZED SYSTEMS<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Validation of computerized systems (GAMP5 environment, 21CFR part11)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>ERP, GED, automated production systems<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Integration, software, unit and non-regression tests<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959847020{padding-top: 13% !important;padding-right: 10% !important;padding-bottom: 13% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs11″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

EQUIPMENT QUALIFICATION<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Laboratory & production equipment<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>FAT, SAT, IQ, OQ, PQ<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>VMP, protocols, reports<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574893356621{padding-top: 11% !important;padding-right: 10% !important;padding-bottom: 11% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs12″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

OPERATIONAL QUALITY ASSURANCE<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Processing Quality Events \/ NC \/ CAPA \/ Change Control<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Coordinating quality action plans<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Quality management with suppliers, production and laboratories<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-3x\u00a0\u00bb width=\u00a0\u00bb1\/2″ animation_delay=\u00a0\u00bb400″ el_wrapper_class=\u00a0\u00bbblocMenuDispositifsPrestations\u00a0\u00bb]

01 <\/span>REGULATORY AFFAIRS
\n<\/span>02 <\/span>RISK MANAGEMENT
\n<\/span>03 <\/span>DESIGN TRANSFER
\n<\/span>04 <\/span>QUALITY MANAGEMENT SYSTEM
\n<\/span>05 <\/span>SYSTEM ENGINEERING
\n<\/span>06 <\/span>AUDIT & CONSULTING
\n<\/span>07 <\/span>MEDICAL DEVICES REGULATION<\/span>
\n08 <\/span>CLINICAL & BIOLOGICAL EVALUATION<\/span>
\n09 <\/span>SPECIAL PROCESS VALIDATION<\/span>
\n10 <\/span>VALIDATION OF COMPUTERIZED SYSTEMS<\/span>
\n<\/span>11 <\/span>EQUIPMENT QUALIFICATION<\/span>
\n12 <\/span>OPERATIONAL QUALITY ASSURANCE<\/span><\/span><\/span><\/h4>
<\/div>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb el_class=\u00a0\u00bbblocDynamiquePrestations2″][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb width=\u00a0\u00bb1\/2″ animation_delay=\u00a0\u00bb400″ el_wrapper_class=\u00a0\u00bbblocMenuDispositifsPrestations\u00a0\u00bb]

01 <\/span>REGULATORY AFFAIRS
\n<\/span>02 <\/span>RISK MANAGEMENT
\n<\/span>03 <\/span>DESIGN TRANSFER<\/span>
\n04 <\/span>QUALITY MANAGEMENT SYSTEM
\n<\/span>05 <\/span>SYSTEM ENGINEERING
\n<\/span>06 <\/span>AUDIT & CONSULTING
\n<\/span>07 <\/span>MEDICAL DEVICES REGULATION
\n<\/span>08 <\/span>CLINICAL & BIOLOGICAL EVALUATION
\n<\/span>09 <\/span>SPECIAL PROCESS VALIDATION
\n<\/span>10 <\/span>VALIDATION OF COMPUTERIZED SYSTEMS
\n<\/span>11 <\/span>EQUIPMENT QUALIFICATION
\n<\/span>12 <\/span>OPERATIONAL QUALITY ASSURANCE<\/span><\/span><\/span><\/h4>
<\/div>[\/vc_column][vc_column width=\u00a0\u00bb1\/2″ el_wrapper_class=\u00a0\u00bbblocRollDispositifsPrestations\u00a0\u00bb][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960110648{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs1″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

REGULATORY AFFAIRS<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Writing and updating CE\/510k marking files<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Regulatory monitoring<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Provide answers to questions from notified bodies and health authorities<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Export submission (worldwide)<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960117404{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs2″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

RISK MANAGEMENT<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>AMDEC Methodology (pFMEA) on products and processes<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Defining the risk management plan and updating\/creating the RMF<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Benefits\/risks documents<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960124848{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs3″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

DESIGN TRANSFER<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Design input, output, verification and documents validation<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Writing and updating DMR\/DHF\/DHR<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Management of the exchanges between R&D and production<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Methods\/industrialization: setting up inspection plans<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960184325{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs4″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

QUALITY MANAGEMENT SYSTEM<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Creating and reviewing the QMS according to ISO 13485 (current version)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Preparing audits and managing post-audit answers<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Training, awareness, and supporting staff in the quality process<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960192334{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs5″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

SYSTEM ENGINEERING<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Management of electromedical systems (specifications, test plan, tests)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>V&V according IEC 62304, 60601 norms<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Writing technical and functional specifications, CDC, URS<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960201304{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs6″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

AUDIT & CONSULTING<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Quality and regulatory audit<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Support the implementation of actions plan<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Change management support<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960208502{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs7″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

MEDICAL DEVICES REGULATION<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Monitoring customer sites to ensure their compliances with new regulations<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>PMS, UDI, clinic, reclassification of medical devices<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Change control management, implementation of changes<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960214312{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs8″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

CLINICAL & BIOLOGICAL EVALUATION<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Writing clinical and biological evaluation reports<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Data recovery (clinical studies or in vivo and in vitro trials data), bibliographic research<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Compliance with MEDDEV 2.7.1 rev4 and MDR<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960221054{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs9″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

SPECIAL PROCESS VALIDATION<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Cleaning, conditioning of MDs, sterilization (ETO, gamma, autoclaves), laser marking and engraving, etc.<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Strategies, worst cases and sampling plans definition<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Trials management with subcontractors<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960228746{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs10″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

VALIDATION OF COMPUTERIZED SYSTEMS<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Validation of computerized systems (GAMP5 environment, 21CFR part11)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>ERP, GED, automated production systems<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Integration, software, unit and non-regression tests<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960236420{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs11″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

EQUIPMENT QUALIFICATION<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Laboratory & production equipment<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>FAT, SAT, IQ, OQ, PQ<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>VMP, protocols, reports<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960246024{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs12″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

OPERATIONAL QUALITY ASSURANCE<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Processing Quality Events \/ NC \/ CAPA \/ Change Control<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Coordinating quality action plans<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Quality management with suppliers, production and laboratories<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

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