CMC Regulatory Support
We can guide and assist in the CMC development including:
- CMC Strategies for Analytical Development, Drug Substances, and Drug Product Manufacturing
- Preparation of CMC regulatory submissions to US and International Agencies
- Technical and Regulatory-Project Planning
- Technology Transfer and Process Validation
- Analytical Transfer and Validation
- Risk Based Approach for Development of Biologics and Biosimilars
- Stability Programs for Drug Substances and Drug Products
QUALITY ASSURANCE SUPPORT
We have the senior quality management experience to create effective quality systems and provide interim quality leadership.
- CMO Selection, qualification, and monitoring via due diligence, qualification audits, quality agreements.
- Facility Design and Validation
- Validation Master Plan Development
- Setting up and Monitoring Quality Systems in Compliance with cGxP Regulations
- Personnel Training
- Mock Pre-approval Inspections