Overview
To gain access to France, foreign medicine and medical device manufacturers are obliged to get authorizations from the National Agency for Medicines and Health Products Safety (ANSM) under the Direction de l’évaluation des dispositifs médicaux. However, manufacturers need an authorized representative anywhere from the EU for obtaining registrations and gain market approvals. Navigating the time-critical approval processes and required Regulatory documentation, challenges market entrant’s compliance efforts.
Freyr, as a specialist global Regulatory partner, assists foreign manufacturers in decoding the local regulatory requirements and comprehensive product classification based on relevant ANSM Regulations. In addition, Freyr assists foreign manufacturers with mandatory Regulatory submissions for streamlined registrations and approvals. Freyr's end-to-end Regulatory Affairs consulting for France span across:
- Medical Devices
- Pharmaceuticals
- Biotech
- Cosmetics
Freyr Offerings
- Strategic Regulatory Consulting
- Regulatory Affairs & Regulatory intelligence
- Registration pathways and license management services
- End-to-end operational support
- Gap analysis
- Dossier preparation, review and management
- Regulatory Submissions
- Drug Information Profile
- Assessment of MAA in the eCTD format for drugs
- Mutual Recognition Procedure (MRP)
- Temporary authorization of use (TAU)
- CE Marking
- Product Information File (PIF)
- Safety Assessment (SA) of cosmetics products
- Review of packaging data
- Literature search and documentation review
- Conversion/update into CTD/eCTD/EU-Nees format
- Management of variation, line extension and renewal dossiers
Freyr Advantages
- Strategic and well-versed local regulatory knowledgebase – with EMEA
- Expert Regulatory team with proven global RA expertise
- Proactive and Collaborative approach
- Quick turnarounds and faster time-to-market
- Keeping abreast with region-specific legislation and Regulatory guidelines