Quality Assurance
Our facilities, equipment and documentation were developed and are maintained to insure that all of our products and procedures meet the strict quality requirements of both our customers and the FDA. Our pragmatic approach to quality is key to our success, production of quality product and the timely completion of our customer’s projects.
All operators, managers and support staff are trained in cGMP’s and company SOP’s on a regular basis. Our ingredients manufacturing line and clinical supplies manufacturing operational systems and facilities have been audited by pharmaceutical and biotech companies, large and small, with excellent results.
Drug master files (DMF’s) are on file with the FDA for both Plasacryl and Marcoat.
Contact our QA group if you require any clarification.
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