cGMP Contract Manufacturing and Services
Our contract manufacturing team works in partnership with customers to provide a “one stop shop” for medical device manufacturers developing specialized or unique products. We apply decades of experience to reduce supply chain complexity, simplify qualification and release testing, tech transfer stable and efficient manufacturing processes, and implement quality control procedures critical to inspection readiness. In addition to aseptic handling, we also provide supply chain management of raw materials and product release testing.
Technical & Regulatory Expertise
We adhere to good manufacturing practices (GMP) and good laboratory practices (GLP), maintaining accreditations and registrations with global regulatory bodies and relevant industry associations. Our cGMP manufacturing facility in St. Paul, Minnesota is ISO 13485 certified, meets ISO 14644-1 Class 7 cleanroom standards and maintains accreditation with the American Association of Tissue Banks (AATB).
Our turnkey manufacturing combined with our integrated testing:
- Reduces supply chain complexity
- Ensures efficient processing, such as simplified billing
- Provides quality control expertise critical to inspection readiness
- Ensures ISO 13485-vendor compliance throughout the manufacturing process
- Incorporates timely raw material in process and release testing
We collaborate with you on each phase of the product lifecycle. Our facility and technicians support engineering trials as well as full commercialization.
- Full GMP & GLP adherence
- ISO 13485-vendor compliance
- Global regulatory compliance including FDA, CBER, CDRH & CDER