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Medpace European Regulatory Affairs


Want to learn more about our expertise in Regulatory Affairs? Simply fill out this form and we will contact you.


GENERAL CAPABILITIES




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Fact Sheet: Regulatory Publishing (PDF)

Fact Sheet: Understanding Orphan Designations and Rare Disease Studies from a Regulatory Perspective (PDF)

Fact Sheet: Regulatory Expertise in Regenerative Medicine

Medpace's European Regulatory Affairs department has many years of experience in early to late phase drug development working as consultants for sponsors, and has close contact with the EMA, national competent authorities, as well as ethic committees.

Our expertise covers various medicinal produce, e.g. NCEs, biological, ATMPs and routes of administration for multiple indications.

Therefore we offer the entire service range of a RA department on a national and EU level:

CMC:

  • Preparation and writing of Medicinal Product Dossiers (CTD/eCTD), in particular the quality modules 2.3 and 3
  • Compilation of dossiers (IMPDs, and dossiers for Marketing Authorization Applications (MAA) and Maintenance)
  • Review/gap analysis of quality documentation
  • Conversion of INDs to IMPDs and vice-versa
  • Compilation of quality components of INDs
  • eCTD compilation for any kind of submission to authorities

For expertise outside EU/US please contact

E-mail: RegAffairs-EU@medpace.com

Scientific Advice (EMA & European national authorities)

Preparation and management of Scientific Advice procedures and Pre-Submission meetings include:

  • Coordiation with CAs and Sponsor - managing the formal procedure
  • Review/writing and compilation of briefing documents

Paediatric Investigation Plan(PIP)

  • Providing scientific input for discussion of strategy development (EMA and combined EMA/FDA PIP)
  • Writing and compilation of the PIP including study outlines and formal application documents
  • Management of PIP applications (incl. submission to EMA)
  • Developing answers - adapting PIP based on a request for modification, if needed

Orphan Drug Application

Preparation and management of Orphan Drug Applications:

  • Coordination with EMA and Sponsor
  • Advice on protocol assistance
  • Review/writing and compliation of application documents
  • Managing the formal review procedure

Marketing Authorization Applications

Support for Marketing Authorization procedures in European countries for chemically defined substances as well as biotechnology products (also Biosimilar) in all dosage forms.

  • National applications
  • Mutual recognition procedure(MRP)
  • Decentralised procedure(DCP)
  • Centralised procedure

Marketing Authorization Maintenance

Post-marketing maintenance of Marketing Authorisations (national, MRP/DCP, CP) in Europe

  • Variation (Quality, Medical/Labeling, Safety)
  • Renewals
  • PSURs (in cooperation with safety)
  • Handling of Sunset clause

SmPC, PIL and Labeling

  • Writing/Updates of SmPC, PIL and Labeling for
    • Investigational medicinal produce
    • Marketed products (e.g. variations, renewals)
  • Coordination of User Testing procedures
  • Adoption of European Safety decisions, e.g. referrals
  • Advice on questions to comparator SmPCs or simplified IMPDs