MedWisdom LifeScience specializes in guiding global medicine and medical device manufacturers through France’s intricate regulatory landscape. Our expert team navigates the complexities of ANSM (National Agency for Medicines and Health Products Safety) requirements, ensuring swift market access. We facilitate essential Regulatory submissions and streamline approval processes, supporting seamless registrations. Trust MedWisdom LifeScience for comprehensive Regulatory Affairs consulting tailored to your needs, from product classification to final approvals in France.

Medwisdom Lifescience offerings

• Dossier Preparation, Review, and Management as per ANSM Standards
• Regulatory Submissions
• Drug Leaflet Profile
• Assessment of MAA in eCTD Format
• Product Information File (PIF)
• Literature Review and Documentation Analysis
• Conversion/Update into CTD/eCTD/EU-Nees Format
• Management of Variation, Line Extension, and Renewal Dossiers