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Analytical method development and analytical method validation

GMP and ICH compliant

Tailor-made validation packages

Reliable analytical methods are essential for trustworthy quality control. GMP-compliant release of APIs is thus only possible with validated methods and GMP-qualified equipment.

In close collaboration with you we will validate methods for your product according to current ICH Q2R guidelines or establish methods listed in international monographs for you. In particular for development and validation services you can trust the long chemical and regulatory experience of our quality control staff. ChemCon develops and validates analytical methods in house since 2001.

If methods and validation protocols are already available, we will transfer and establish your methods in our labs.

A close contact with our customers has always been one of our main values. Frequent reporting assures that you are up-to-date regarding the progress of your project at any time.

For reliable quality control:

Transfer of existing methods following customers’ validation plans
Establishment of methods according to international monographs (e.g. Ph. Eur., USP)
Development and Validation of new methods to your requirements
Risk assessment of new methods
Compilation of GMP-compliant validation protocols
Method validation
Comprehensive validation report

ChemCon’s chemist will evaluate in detail how we can best support your project:

Your inquiry for ChemCon’s chemists