Analytical / Process validation

Your project’s success is our priority and we place great importance on timely and thorough analytical and process validation services.

In our state-of-the-art R&D laboratories, our chemists design synthetic routes for your target molecules and develop optimal commercial processes.

By developing and validating analytical methods in parallel with synthetic development, we can ensure your project’s rapid progress.

Our process validation services include:

  • Establishing validation protocols
  • Analytical method development
  • Range finding for critical process parameters
  • Optimization/design of experiments (DoE)
  • Laboratory reproducibility studies
  • Scale-up and technology transfer
  • Validation summary reports
  • Active change control system to ensure continued validated operation

Our analytical validation services include:

  • Stability indicating and focused degradation studies
  • Impurity and limit tests
  • Impurity isolation and identification
  • Method validation transfers