DSI evaluates the integrity and completeness of CMC documentation supporting CTD submissions to identify gaps in your drug development programs that could interfere with obtaining timely regulatory approvals.
DSI’s multi-disciplinary teams of CMC specialists are rapidly deployed to review available CMC documentation, including API chemical characterizations, batch history, process validation, analytical method development, specifications, stability, quality systems and more.
Using a risk assessment approach, we assign a critical/major/minor/ best practices rating scale to each technical and quality element of Modules 2 and 3 CTD.
Within days of completion of the analysis, you receive a written report:
- Gap analysis and risk assessment of the CMC program
- Highlighting areas of potential concern
- Offering suggestions for remediation
You will also receive a two-hour teleconference with the entire team of CMC specialists to answer technical questions.
DS InPharmatic’s proprietary CMC HealthChek™ is a low-cost fixed fee service that gives managers the information and tools they need to prioritize resources and minimize the risk of delays to important product development milestones.