The appropriate quality level to smooth face current legislation 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 validation. 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 a dedicated plant in Thane where we can manufacture batches of placebo and even drug product for creams, ointmens, gel and an ongoing solid form facility. This hugely accelerates our pace of method development and validation. A resource greatly valued by our clients.