Method Development, Optimization and Validation

Method Development, Optimization and Validation

The expert personnel at SGS laboratories have extensive knowledge and experience in pharmaceutical method development and validation for raw materials, APIs, finished products, cleaning, and bioanalytical testing.

We offer development and documentation of analytical protocols and reports for proprietary and non-proprietary test methods and manufacturing processes. This is conducted in compliance with the Notes for Guidance Validation of Analytical Procedures, Definitions and Terminology and Validation of Analytical Procedures, Methodology by the ICH (Q2A, Q2B) and FDA guidelines.