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