Biologics / Large Molecule Analytical Services
Catalent’s analytical center of excellence for large molecules based in Kansas City, MO, has an exceptional regulatory history with inspections performed by our portfolio of customers as well as over 10 reputable regulatory bodies including FDA, MHRA, EMA and others.
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.
ELECTRONIC SYSTEMS
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.