The Quality Assurance Program at Molecular and Cellular Therapeutics ensures compliance with regulatory requirements and external standards set by the FDA and the current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP), as stated in the Code of Federal Regulations.
The program is staffed by experienced quality assurance specialists who have completed formal cGMP training and who manage the quality systems fundamental to facility compliance. We assure that customer requirements are met by integrating a quality system, which meets regulatory requirements and enables rapid development for therapeutic products. Our quality system provides a platform that creates meaningful synergy with other functions and groups to ensure continual improvement in processes, products, and people.
Regulatory Compliance System
- Determining the need for an IND/IDE
- Determining the contents of the IND/IDE applications
- Providing guidance and oversight of CMC (Chemistry, Manufacturing, and Control) sections of INDs
- Providing education and templates to help sponsor-investigators comply with their regulatory obligations
- Providing assistance in preparing forms and communications to FDA as needed or required