Method Development Method Validation Method Transfer Stability Studies and Evaluation Structure Elucidation and Evaluation

It involves proving that analytical methods are appropriate for their intended purpose, a key requirement set by regulatory bodies at specific phases of the drug approval process.

Pharmaffiliates typically validates test methods for

  • API
  • Drug products
  • Drug product containers

The process starts with a validation protocol, thoughtfully reviewed and signed by both the client and Pharmaffiliates. Our team then carries out the lab work carefully, strictly following the agreed method to ensure every step meets your expectations.

Large Molecules
CPHI INDIA- 28, 30 November