Robust Methods.
Zero Surprises.
A method is only as good as its validation. We specialize in developing and validating methods that stand up to regulatory scrutiny. We strictly adhere to ICH Q2(R2) and FDA guidelines, ensuring your methods are robust, reproducible, and transfer-ready.
Key Capabilities:
- Method Validation:
Full compliance with USP <1225> (Validation of Compendial Procedures). - Method Transfer:
Seamless transfer protocols per USP <1224>. - Forced Degradation Studies:
Stress testing to demonstrate stability-indicating properties. - Optimization:
Refining existing methods for better peak resolution and run times.
Do you require help or further information?
Contact us! We are happy to advise you: