Regulatory Support/Quality Assurance
Albany Molecular Research Inc. (AMRI) provides the Chemistry, Manufacturing, and Control (CMC) regulatory support and Quality Assurance services essential during all phases of drug development up to and including process validation and marketing applications. These services include:
- Management of required Good Manufacturing Practice (GMP) documentation and compliance procedures
- Preparation of CMC sections of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), European filings, applicable Drug Master Files/Master Files, and Abbreviated New Drug Applications (ANDAs)
- Ensuring the quality of AMRI’s GMP manufacturing and testing services through routine review of documentation, including but not limited to procedures, batch records and laboratory records.