Regulatory Consultancy

regulatory submissions pharmaCROS NT’s Regulatory experts can provide support through all stages of drug development. We can help you put together a regulatory strategy document to determine your pathway forward. Plans can be validated by preparing briefing documents and support through Regulatory Agency meetings both in Europe (nationally and with EMA) and in the US. We can manage your development program from the very early stages of development through to submission.

CROS NT can offer some of the best regulatory experience available. Our regulatory professionals can provide guidance through the Scientific Advice process and support with Regulatory Agency meetings both in Europe (nationally and with EMA) and in the U.S. We can give program support from the very early stages of development through to submission. Consultancy includes:

  • Regulatory Strategy
  • Scientific Advice
  • Orphan Drug Designation
  • Paediatric Investigation Plan
  • Clinical Trial Applications
  • Procedural Management (Centralized, Decentralized and Mutual Recognition)
  • OTC Switches
  • PIL User Testing
  • Due Diligence
  • Training and Mentoring