Method Development and Validation
Our analytical development and Quality Control teams have in-house access to a comprehensive range of state-of-the-art analytical techniques and extensive experience in development and validation of analytical methods. Operating from our purpose-built modern laboratories our analytical and quality control teams offer a full range of services providing scientifically robust data you need for regulatory submissions and to guide your next steps.
Our teams develop methods to analyse the identity, strength and purity of products and raw materials, as well as developing stability indicating methods. We operate with state-of-the-art technology to support our innovative approaches to achieve best results and development capabilities. We have a life cycle approach to method development and routinely develop methods applicable throughout the life cycle of the product.
We also provide analytical validation in compliance with the European Pharmcopoeia (Ph. Eur) the US Food and Drug Administration (US FDA), current Good Manufacturing Practices (cGMP) and International Council for Harmonisation (ICH) requirements.