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HomeLife SciencesBiopharmaceutical ServicesLaboratory ServicesBioanalytical ServicesMethod Development Optimization & Validation
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.
Once a method is validated, it may require transfer. Method transfer may involve comparative testing, co-validation between two sites (lab-to-lab), complete or partial revalidation and comprehensive documentation (transfer plan, protocol, report).
Whether SGS’s Life Science Services is the developing or the receiving laboratory, we can assist you with your method transfer requirements.
Our Method Development and Validation Services include:
Call us today to discover more.