Regulatory Affairs

Understanding the importance of the EU Clinical Trial Directive, clinical trial authorization, the increasingly important requirements for running trials on children, requirements for managing investigational medicinal product, legal aspects of clinical trials, pharmacovigilance, data management, GCP and/or ISO requirements and regulatory inspection are the most important areas of regulations and guidelines controlling clinical trials.

Services we offer

  • Regulatory Authority application / approval management
  • Strategic regulatory input to project teams throughout drug development and its lifecycle
  • Specific guidance to project teams / functions on regulatory issues such as legislation, guidelines and procedures
  • Leadership in interactions with health authorities in the Czech Republic and other countries
  • Preparation of registration documents for Marketing Authorization Application (MAA)

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