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Manufacturing

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