At Blackbriar Regulatory Services we specialize in helping small to mid-sized domestic and international companies navigate t ... he 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 technical teams, made up of industry experts with backgrounds in medical devices, diagnostics, pharmaceuticals, cosmetics, and tobacco. Since our inception, our organization has perfected our processes in cost efficient manufacturing, analytical testing, regulatory compliance audits and filings, rigorous project management, packaging design, and product stewardship for our international customer base ranging from the United States to Europe and Asia. Our key to success is speed and flexibility, while never compromising quality or our customers’ confidential information. Our promise is to deliver you results without excuses that are right the first time, every time. read more