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, provides the following benefits:
- 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
With our manufacturing programs, 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