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.