USA: +1 617 939 9497 | UK: +44 2039 962936 | EU: +34 607 939 266
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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.

Contact us to request more information or get a quote

US: +1 617 939 9497

 UK: +44 2039 962936

EU: +34 607 939 266