GLP-certified viral testing and clearance services

Syngene offers GLP-certified viral testing and clearance services with flexible scheduling and rapid turnaround, supporting over 100 global clinical programs. Their facility is India’s only GLP-certified site for viral safety studies, ensuring compliance with FDA, EMA, and WHO regulations. Services include viral clearance studies, cell bank testing, and in-process/batch testing for biologics.

Nitrosamine Assessment

Syngene offers comprehensive nitrosamine evaluation through mutagenicity testing, including Enhanced Ames, HPRT, and TK6 assays along with carcinogenic potency categorization (CPCA) to support regulatory‑compliant impurity risk assessment.