Blackbriar Regulatory Services

at blackbriar regulatory services we specialize in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their fda regulated product concepts to market. we offer prototyping and product development support for medical device and diagnostic companies consistent with iso 13485 and 21cfr820, manufacturing, assembly, packaging and testing services. we are also specialists in process validation with in-depth experience conducting iq/oq/pq protocols. this is achieved through our state-of-the-art facilities, conforming to standards set by fda and cgmp, which include over 5,000 sq2 of controlled environment manufacturing space including an iso certified class 6 clean room, high-speed filling equipment, iso 17025 analytical lab providing organic analysis, inorganic analysis, and chromatography, a pharma-style quality system, and part 11 compliant sap based erp system. all of this is managed by our highly experienced leadership and technic