Regulatory Affairs for Drug Development Programs in Europe
Sofpromed provides regulatory strategy services for biotech and pharma companies working on drug development programs in Europe, including:
- CMC, non-clinical, and clinical development plans
- Feasibility of IMP designation following fast-track paths
- Preparation of orphan drug designation (ODD) applications
- Inclusion of IMP in the Priority Medicines (PRIME) program for expedited approval
- Preparation and submission of pediatric investigational plans (PIPs)
- Regulatory roadmaps, gap analysis and feasibility assessments
- Preparation for scientific advice meetings with European Medicines Agency (EMA)
- Support to request protocol assistance from EMA
- Writing of Investigational Medicinal Product Dossier (IMPD) and Investigator’s Brochure (IB)
- CTIS clinical trial submissions
- Marketing authorization applications (MAA) including common technical dossier (CTD) and post MAA regulatory maintenance
Please contact us if you need regulatory strategy services in Europe.