Qualification

Comprehensive biopharma activities integrated with expert IQ, OQ, and PQ services ensure all facilities, systems, utilities, and equipment meet design requirements and are verified as ‘fit for intended use’ with appropriate documentation resulting in efficient and cost-effective approvals.

We follow the latest best practices outlined by the FDA, EMA, ICH, WHO, ISPE, PDA, ISO, and other global regulatory agencies to ensure your project meets all regulatory requirements while adhering to your company’s site-specific procedures and policies.