SRC provides expertise in drug chemistry, manufacturing and controls (CMC) to meet FDA requirements according to the stage of development. Most FDA submissions fail due to CMC deficiencies, so getting it right for drug and medical device compliance is critical. We also have extensive expertise in applying the regulations for medical device manufacturing, and setting up quality systems to meet FDA’s requirements (QSRs) for new companies and products.
Our drug CMC and medical device manufacturing compliance support services include:
- Review and assessment of drug CMC plans
- Define requirements for analytical methods, process development, specifications, and stability studies
- Audits for GMP compliance
- Mock FDA inspections
- Development, preparation, and review of CMC documentation
Medical Device Compliance
- Setting up Quality Systems and SOPs for new start-ups
- Quality Systems Regulation (QSRs) compliance assessment
- Definition of manufacturing requirements for 510(k) and PMA submissions
We correspond frequently with the FDA, and our excellent access gets the critical issues addressed in a reliable manner.