Regulatory Affairs

Regulatory Affairs

Check and preparation of documents for a successful approval

Food and drugs should not just be tasty, safe and effective, but also need to meet different legal and regulatory requirements. This includes, for example, scientific evidence and a deep understanding of the (inter-)national legal requirements. It is important to know the (inter-)national procedure and which documents need to be submitted for the successful marketing authorisation. I provide a combination of scientific and legal basis and pragmatism, ingenuity and a look beyond the rim of your tea cup, because new ideas oftenly need to strike out in a new direction.

Since many years, I advise companies from Germany and Austria concerning regulatory affairs.
Additionally, you profit from my qualification as officially licensed and sworn expert for pharmaceuticals, food, cosmetics (Chamber of Commerce and Industry for Munich and Upper Bavaria), more about this services:

Management of the following regulatory tasks:

  • Advise for product classification (food supplement, food for special medical purposes)
  • Check of formulation (ingredients, minimum/maximum levels)
  • Check of health claims
  • Scientific substantiation of health claims
  • Scientific substantiation of the dietary purpose
  • Preparation of dossiers
  • Check of labelling (mandatory, voluntary texts)
  • Search of literature
  • Application and notification at authorities (necessity and implementation)
  • Advisory opinion concerning complaints of authorities or competitors

Network-Management concerning projects which need a cooperation with a lawyer or laboratories.

Your requirement is not covered? Call me to discuss if and how I can give you support!

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