Quality Control, Analytical Development & Quality Assurance

Regulatory Affairs

Understanding global regulatory requirements is a critical step on the road to approval. Let the DDR consultants help you through this maze! With experience in drafting, editing and submitting regulatory documents, DDR has assisted clients across all phases of drug development, often saving significant time and costs.

Past projects have included:

Case Study 1: Peptide Product

Initial Contact: VC in-licensed two compounds with aggressive clinical trial start dates and three medical/scientific employees.

  • Wrote CMC sections of IND
  • Developed Product Specifications
  • Selected DS/DP/FG Manufacturing and Distribution Vendors
  • Managed Manufacturing and Distribution Operations
  • Performed Product Release

Results: Clinical trials underway. Second compound DS in production.