DDReg provides tailored, end-to-end solutions that expedite market entry and minimize time-to-approval—enabling your organization to make well-informed decisions and attain commercial success in global markets.
DDReg Pharma – Your Strategic Compliance Partner in France
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✔ Expertise in pharmaceutical & medical device regulations
✔ Trusted support for navigating France’s highly regulated market
✔ Strong liaison with ANSM
Regulatory Affairs Services:
-Market entry strategy & regulatory pathway planning
-Dossier preparation (CTD/eCTD) – National, MRP, DCP & Centralized procedures
-Marketing Authorization (MA) support
-Lifecycle management (variations, renewals)
-Medical device compliance (EU MDR & CE marking)
-Labeling & French localization compliance
-Gap analysis, remediation & regulatory intelligence
-Local representation & direct coordination with ANSM
Pharmacovigilance (PV) Services:
-PSURs & PBRERs preparation and submission
-Signal detection & risk management planning (RMP)
-PV system setup, maintenance & audit readiness
-EU QPPV & France local PV contact (RPV) support
-Local literature monitoring for safety signals
-End-to-end post-market surveillance compliance
