Analytical method development for API, Drug Products, Medical Devices and Cosmetic Products
The appropriate quality level to meet current regulations could be different in the different stages of the product process development. We choose the optimal level of assurance to meet your goals in a timely and cost-effective way. At the high limit of quality requirements we can conduct full compliant ICH method development. We offer:
- Method development plan definition.
- Background information gathering.
- Laboratory method development, including sample preparation.
- Generation of test procedure.
As a capability that distinguishes us from other companies, we have the equipment and the ability to manufacture batches of placebo and even drug product for creams, ointments and gels.This hugely accelerates our pace of method development and validation. A resource greatly valued by our clients.