A-consult A/S
Major Drugs - N/A, N/A, DK
A-consult A/S Employees
A-consult A/S Details
A-pharmaconsult, in Grasse and Issy-les-Moulineaux, offer a full range of services in International Regulatory Affairs for Drugs, Medical Devices, Cosmetics and Food Supplements:- writing of Marketing Autorisation Application dossiers (all Modules),- preparation of Export' MA dossier,- maintenance of MA dossiers: writing of Product Information (SmPC, PIL), gap analysis, update and conversion into CTD format (eCTD, NeeS), writing of variation applications, renewal and extension dossiers,- bibliographical research, analysis and writing of Non-Clinical documents (Modules 2.4, 2.6 & 4, NCES), Clinical (Modules 2.5, 2.7 & 5, CES) and Expert Reports,- product positioning (pharmaceutical, medical device, cosmetic, food supplement) and regulatory strategy,- management and coordination of submission to the Health Authorities (National procedures, MRP, DCP, CP), follow-up and answering to questions from the Authorities,- writing of Technical Dossiers for Medical Devices (class 1 to 3) according to ISO requirements, including Clincal Evaluation Report, Biological Report, Risk Management, Essential Requirements, Manufacturing of the Device, artworks,- audit and improvement of Quality Systems (GMP, ISO13485, ISO22716),- preparation and submission of CTA dossiers,- regulatory consulting: regulatory positionning, regulatory strategy, product development assistance, assistance for manufacturing transfers, literature surveillance, - evaluation of MA dossiers, due diligence, - management of User Testing,- management of publishing (eCTD, Nees),- writing of CMC veterinary dossiers and cosmetic dossiers,- writing of training course documentation for your medical representatives' team,- food supplements: formula evaluation, strategy, regulatory compliance, technical dossiers.A-pharmaconsult is part of a Danish Group, A-Consult Group, located in Copenhagen, specialized in Regulatory Affairs and founded in 1983.
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