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Method Development & Validation

Method Development & Validation

Verifying that a particular analytical method is fit for purpose. Analytical method development and validation are an essential requirement in the discovery, development, and manufacture of pharmaceuticals.

All of our method development and validation conforms to current Good Manufacturing Practices (cGMP) and ICH guidelines (ICH Q2(R1)) with the aim of demonstrating suitability of the method for its intended purpose.

Our extensive method development and validation experience covers:

  • API and drug product methods
  • Stability indicating methods
  • Remediation of older methods
  • Compliance with ICH under cGMP quality

 

For further information and prices please contact us or call +44 (0)115 973 9012

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