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DSM in Medical

Regulatory filing & clinical trial support

DSM’s experienced Clinical and Regulatory Affairs Staff has a proven track record of achieving US and foreign regulatory approvals. Implementing our regulatory strategy has involved conducting large and small-scale clinical trials with leading medical institutions throughout the world.

Whether seeking regulatory approval independently or in collaboration with our valued sales partners, DSM can provide:

  • Regulatory strategy consultation
  • U.S. and International regulatory filing 
  • U.S. and OUS clinical trials
  • Clinical evaluation reports per ISO 14155
  • Clinical investigation plan development and trial management