ClinReg Consulting Services, Inc is committed to providing working solutions to help you achieve your clinical and marketing goals. ClinReg is your partner in navigating the complexities of regulatory approval and works with you to develop and implement global strategies, prepare submissions, plan testing or manage communications with regulatory agencies.

Our approach allows you to maintain control over your project, while at the same time gaining the benefit of external support and specific expertise. Our responsive, flexible team approach to managing regulatory challenges of allows us to be instrumental in helping you successfully gain approval from the FDA.

Our regulatory services include:

  • Clinical and regulatory development plans
  • Pre-IND, Pre-IDE, EOP2, pre-PMA, pre-NDA meetings
  • Clinical trial design
  • Investigational new drug (IND) and investigational device exemption (IDE) submissions
  • Premarket notifications (510k)
  • Premarket approval applications (PMA)
  • New drug applications (NDA)
  • Humanitarian use designation (HUD) and device exemption (HDE) submissions
  • Combination products and request for designation (RFD)

We welcome your inquiries. Contact us to learn how ClinReg Consulting Services, Inc. can assist your company in reaching its goals successfully.