Regulatory Support

MedPharm has gained experience in the design and drafting of regulatory components used in new drug and generic applications with a variety of regulatory authorities worldwide. Our services include helping clients with:

  • Preparation of appropriate pre-clinical / CMC sections for your regulatory documents: IND,CTX, PLA, NDA, BLA, ANDA, MAA
  • Presenting pre-clinical aspects of your product development to the appropriate regulatory authorities
  • Supporting the design of an appropriate clinical strategy and study protocol design including endpoints

 Clinical Studies

MedPharm offers a comprehensive clinical trials service in dermatology. MedPharm has access to the significant resources of Kings College London, including the St. John’s Institute of Dermatology. Specialist services include autoimmune and inflammatory skin diseases, psoriasis, cutaneous lymphoma, and melanoma together with the National Epidermolysis Bullosa Centre.

MedPharm offers the following clinical services to clients:

  • Compilation of investigator’s brochures
  • Study design, protocol writing and review
  • Case Report Form design and review
  • Ethics  submissions
  • Clinical Research Organisation selection
  • Study management and monitoring
  • Arrangement of data management and statistics
  • Final Study Report writing and review
  • Writing of safety summaries and expert reports
  • ICH SOP writing and review