Regulatory Consulting

We support your organization and Regulatory Affairs department if you need extra resources or specialized competencies to support approval of new products or during life cycle management

  • A strategic approach to decision on type, contents and timing of regulatory submissions incl. meetings with the authorities and responses to comments from authorities
  • Preparation and/or support during approval of regulatory submissions (clinical trial applications, marketing authorisation applications as well as variation applications also including Active Substance Master Files).

 

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