Biologics / Large Molecule Analytical Services
REGULATORY / COMPLIANCE
Full-service capabilities, streamlined processes, cost-effective solutions
Catalent has an exceptional regulatory history with FDA, MHRA as well as other regulatory agencies based on the site. Our standalone analytical testing facilities in Kansas City, MO and Morrisville (RTP), NC are routinely audited by regulatory agencies and many clients’ quality groups. Regulatory history reports are available upon request.
Catalent has extensive experience introducing new products to the market, and this is facilitated by the strong compliance to regulatory guidelines assuring clients of minimal risk to their product and timelines.
Catalent utilizes validated electronic systems to ensure compliance and to facilitate the activities associated to laboratories. The electronic systems are available across multiple areas of laboratory testing:
- Stability inventory and reporting system
- Chromatography acquisition system (Openlab, Empower, and TurboChrom)
- Instrument specific software with complete CSV package and periodic assessments
- LIMS sample tracking
- Quality document system
- Building management systems with alarm notifications.