Analytical and stability services support reliable data generation throughout pharmaceutical development and commercialization. Support includes analytical method development, validation, and verification for APIs, intermediates, and drug products in accordance with ICH and global regulatory guidelines. Method transfer, troubleshooting, and comparability evaluations are performed to meet data integrity across sites.

The stability programs are designed and managed to satisfy regulatory expectations, such as long-term, accelerated, and stress studies. The interpretation of stability data assists in setting up of shelf life, retest, and storage.

Early integration of analytical and stability strategies reduces regulatory risk and confirms data packages are well-documented, scientifically justified, and appropriate for inclusion in INDs, NDAs, DMFs, and other submissions.