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:
- Global Regulatory Expertise
- IND, BLA, NDA, CTD
- Authoring / Submissions
- Regulatory Agency Inspection and Response Support
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.