Contract Testing Lab

We support sponsor who are looking for lab who can conduct nitrosamine impurity identification and quantification, extractable and leachable tests, dissolution, related substance and assay test.

We have a robust process in place for selecting contract testing lab (CTL) sites to ensure they meet the required standards of compliance with Good Laboratory Practice (GLP) norms. Conducting thorough due diligence audits is essential to verify that the selected CTLs adhere to the appropriate SOPs and policy documents, thus ensuring the reliability and integrity of the data generated.

Audit of site includes : 

• Facility infrastructure
• Quality management system
• Equipment calibration and maintenance
• Personnel qualifications and training
• Documentation practices
• Sample handling and storage procedures
• Quality control measures and adherence to regulatory requirements
• IT infrastructure and software validation
• Archive, Data back up