Leveraging our deep scientific expertise and proven track record, AMRI provides regulatory support for chemistry, manufacturing and controls (CMC) and the quality assurance services essential during all phases of drug development, including process validation and marketing applications. Our services include:
- Management of required good manufacturing practice (GMP) documentation and compliance procedures
- Preparation of CMC sections of investigational new drug applications, new drug applications, European filings, applicable drug master files/device master files and abbreviated new drug applications
- Ensuring the quality of AMRI’s GMP manufacturing and testing services through routine review of documentation, including procedures, batch records and laboratory records