Regulatory Affairs

Camara and Partners is mainly acting in Switzerland and Europe.
We provide strategic advice as well as operational support and tailor services according to our clients’ specific needs.

Pharmaceuticals (Synthetic, Biologics, ATMPs)

  • Elaboration and submissions of documents to Authorities/Institutions/Ethics Committees on behalf of the client
  • Agency consultation and Scientific Advice
  • Orphan drug designation
  • Clinical trial applications
  • Marketing authorisation applications (eCTD format)

Medical Devices & Combination Products
We complement your technical knowhow, by guiding you in product risk classification and Notified Body relations, and consult with Competent Authorities.
Our services comprise:

  • Essential requirements elaboration
  • Risk management
  • Technical file elaboration
  • Medical writing
  • Clinical trial applications
  • CE marking process
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