France represents one of Europe’s largest and most influential pharmaceutical and medical device markets, with a rigorous yet efficient regulatory framework overseen by the ANSM.
The Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) regulates medicines, medical devices, and health products in France, handling national procedures, clinical trials, pharmacovigilance, and collaborating with the EMA for centralized authorizations. MedWisdom LifeScience specializes in guiding global manufacturers through France’s intricate regulatory landscape. Our expert team ensures swift market access by managing complex ANSM requirements, facilitating regulatory submissions, streamlining approval processes, and providing comprehensive Regulatory Affairs consulting — from product classification and dossier preparation to final approvals and ongoing compliance in France.
Get France Compliance Support
Expert preparation, scientific review, and management of regulatory dossiers fully compliant with ANSM and EU guidelines.
Complete support for national, MRP, DCP, and centralized submissions to ANSM and EMA, including validation and follow-up.
Creation, review, and optimization of Summary of Product Characteristics (SmPC), patient information leaflets, and labeling in French.
Thorough assessment and quality control of Marketing Authorization Applications (MAA) submitted in eCTD format to ANSM.
Compilation, maintenance, and updating of Product Information Files for cosmetics and other relevant products per French/EU requirements.
Comprehensive literature searches, gap analysis, and documentation review to support regulatory dossiers and safety assessments.
Seamless conversion of dossiers to CTD, eCTD, or EU-NeeS formats, including updates and technical validation for ANSM/EMA submissions.
Full lifecycle support including classification, preparation, submission, and tracking of variations, line extensions, and renewals with ANSM.
Partner with Medwisdom for expert, efficient, and fully compliant regulatory support in France — from dossier preparation and ANSM submissions to lifecycle management and sustained market success.
Contact Our France Regulatory Experts