Biologics Analytical Services

Regulatory / Compliance

Full-service capabilities, streamlined processes, cost-effective solutions

Catalent Pharma Solutions has an exceptional regulatory history with FDA, MHRA as well as other country regulatory agencies based on site. Our analytical testing facilities in Kansas City, MO and Research Triangle Park, NC are routinely audited by regulatory agencies and many clients quality groups and have proven to have an exceptional regulatory and compliance record.  Regulatory history reports are available to clients and, hence, our clients’ can be assured of receiving good adherence to compliance  when supporting their products.   

Catalent has extensive experience of 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.