QCL dedicated Stability team provides services for all stages of drug development, from early R&D to Commercial/Post Approval studies, in full compliance with ICH, FDA and other regulatory requirements.
We offer the following services:
o Stability Protocol Design
o Long Term Stability
o Accelerated and Intermediate Studies
o Drug Substance Stability Testing
o Stability testing for IND, NDA, ANDA
o Commercial/Marketed Products
o Formulation Evaluation Stability Testing
o Forced Degradation Studies
o Photostability and Temperature Cycling
o Full ICH Conditions
