DDReg Pharma – Your Strategic Partner for Compliance & Drug Safety in Germany

✔ Expertise in pharmaceuticals, biologics & medical devices
✔ In-depth knowledge of Germany’s strict regulatory environment
✔ Direct coordination with BfArM and Paul-Ehrlich-Institute

Regulatory Affairs Services:

-Regulatory strategy & market entry planning
-Marketing Authorization (NCEs, generics & biologics)
-CTD/eCTD dossier preparation, publishing & submission
-CMC & API-DMF advisory support
-Lifecycle management (variations, renewals & amendments)
-Labeling & artwork compliance (SmPC, PIL & packaging)
-Gap analysis, due diligence & remediation
-Medical device regulatory support (EU & Germany frameworks)

Pharmacovigilance (PV) Services:

-ICSR case processing & adverse event reporting
-Aggregate safety reporting (PSURs, DSURs, ASRs)
-Signal detection & risk management (RMP & REMS)
-Literature monitoring (global & German sources)
-PV audits, compliance checks & inspection readiness
-End-to-end drug safety system support

Ensure seamless approvals and maintain the highest standards of patient safety in Europe’s largest pharmaceutical market.

Contact DDReg Pharma today – your trusted partner for Regulatory Affairs Services And Pharmacovigilance Services in Germany!