Whenever new materials or new active pharmaceutical ingredients are being developed, reliable and reproducible analytical methods are required for a successful development and manufacturing process. To ensure the quality of the product, appropriate methods have to be selected at each stage of the process.
Method development and method validation are important to demonstrate that the testing procedures meet the objectives and are suitable for their intended use.
Effective method development
Validation of methods according to the most up-to-date guidelines and GMP requirements
(e.g. EMA, ICH).
Archiving of SOPs and validation data