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Regulatory Affairs


Successful medical product development and registration requires a sophisticated regulatory strategy supported by timely availability of high quality regulatory documentation and effective communication skills. Our experienced global regulatory team helps achieve this by providing both the strategic and tactical support you need to ensure your success.

Our team offers global regulatory support for drug, biological and medical device products in preclinical development through post-approval surveillance and marketing. Our services include strategic regulatory consulting, preparation of regulatory submissions and global regulatory liaison.

    Core services.

  • Drugs, biologics, medical devices
  • Regulatory consulting
  • Product development planning
  • Regulatory intelligence
  • Regulatory liaison
  • Investigator brochures
  • Clinical trial authorizations IND, CTA, IDE
  • Marketing authorizations NDA, ANDA
  • Drug master files
    Client benefits.

  • Experience with regulations and regulatory agencies in North America, Europe and Asia
  • Strong expertise with new European Clinical Trial Directive
  • Local/regional/global capabilities
  • Highly educated, experienced staff including former FDA officials
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