REgulatory Affairs

At the outset of your development plan, sound advice from a Regulatory Consultant is critical.

The Regulatory Affairs team at CDS has the real world experience to guide you in the best strategic direction, saving valuable time and resources.


From strategic planning to submission, CDS offers complete Regulatory Consulting services:

  • Regulatory planning

  • New Drug Applications (NDA’s), Abbreviated Drug Applications (ANDA’s), Supplemental New Drug Applications (SNDA’s)

  • Clinical Trial Applications (CTA’s)

  • Label and Advertising Review

  • Drug Master Files (DMF’s)

  • Other Regulatory Compliance Issues