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REGULATORY AFFAIRS SERVICES

We provide strategic advice as well as operational support and always tailor services according to the specific clients’ needs.

This means that we either guide our clients in the specific document elaboration and submissions or develop the documents and submit to Authorities/Institutions/Ethics Committees on behalf of the client. 
The main regions where we act are Europe and Switzerland.

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Pharmaceuticals & Biologics
Long-standing relations with agencies allows us to liaise easily for our clients and/or to act on our client’s behalf for

  • Agency consultation and Scientific Advice
  • Orphan drug designation
  • Clinical trial applications
  • Marketing autorisation applications (eCTD format)
     
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Medical Devices & Combination Products
Our competences can complement your technical knowhow. We guide 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
  • Clinical trial applications
  • Quality system set up
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Food Supplements
Our services cover Swiss food supplement regulations and how to comply with. This includes :

  • Ingredient listings
  • Restriction limits
  • Swiss labeling
  • Import conditions
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