Analytical Method Validation

PolyCrystalLine specialises in analytical method development and validation, which are essential components in the discovery, development and manufacture of pharmaceuticals. We provide the development of analytical methods for the following applications:

• Quality assessment of APIs, starting material and final product
• Characterization of APIs
• Quantity assessment of APIs and formulated APIs

ICH Validation
The International Conference on Harmonization (ICH) has issued guidelines for analytical method validation. The methods developed are validated for testing scientific integrity which complies with the ICH guidelines, including preparation and validation protocols and reports.

PolyCrystalLine offers accurate and reliable analytical method validation services supported by our team who are experienced in validating procedures and analytical method development.

For more information or to discuss analytical method validation please contact us directly.