Regulatory Support
Services for cGMP Compliance

1) FDA Compliance for Manufacturing of Ab intermediate, DS and DP (Combination products with drug/device): 

  • Assessment of clonal derivation for the production cell line

  • Safety testing of MCB, WCB and UPB

  • Viral clearance validation

  • Process validation strategy

  • Stability data requirements

2) FDA Compliance for Raw materials, Manufacturing process, Testing method, Formulation, Container Closure and DP  Format change

3)FDA Compliance for IPC, Release and Stability testing and method validation: Submission requirements for Methods SOPs, Method qualification and validation, and Reference standard qualification

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