Regulatory Services

Regulatory approval can be a long and complex process. Without high level knowledge of regional regulatory standards, progress can be slow throughout development and regulatory filing.

We provide comprehensive consultancy solutions to help you identify the shortest route to market. Our experienced multilingual teams work closely with regulatory agencies and offer consulting and operational support throughout the whole development life cycle.

Regulatory Services

Our locally based RA experts can provide local support including but not limited to:

  • Legally needed role and responsibility of Local Regulatory Contact Person
  • Liaising with the Regulatory Authorities
  • Regulatory Intelligence
  • Availability as needed
  • Support with review, implementation and submission of variation
  • Local language support and translation
  • Scientific Advice
  • Other ad hoc activities

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