Method Development & Validation

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for sample release data, testing of stability samples, testing of active ingredients and to provide data to support specifications.

For the assay of the active ingredient and any relevant impurities we would normally validate the method used in-house, such validation being designed to meet the requirements of SANCO/3030/99 rev.4.

We have a large database of successful method validations and would be happy to discuss your requirements.

We can also offer partial validation services, method improvements or updates to meet current regulatory requirements, methods transfers and independent laboratory validations.

Please contact us for a tailored quotation based on your regulatory requirement.