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About AccuReg®

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AccuReg® is a regulatory, compliance and technical consulting firmAccuReg is a regulatory, compliance and technical consulting firm serving the pharmaceutical, medical device and diagnostic, and over-the-counter drug industries. Since 1987, we have helped hundreds of domestic and international clients to achieve compliance with FDA’s Good Manufacturing Practices and other regulatory requirements, gain U.S. market approval and ensure the quality of their products.

We serve developers and manufacturers of the following medical product types: Ethical (prescription) pharmaceuticals; biological and biotech products; combination products; over-the-counter drug products; prescription and over-the-counter medical devices and diagnostic products; in vitro diagnostic products for home and clinical use; computer-controlled medical devices; accessory and standalone software devices; and cosmetics. We also serve developers, manufacturers, and end-product users of manufacturing, laboratory and process software.
  Company Background  
  AccuReg was founded in 1987 to serve the healthcare industries with expert regulatory, compliance and technical support. Our Associates are Regulatory Affairs professionals, chemists, engineers, biologists, quality specialists and technical writers with industrial and regulatory experience. Their backgrounds are in:

  • Quality systems
  • Regulatory affairs
  • Research and development
  • Manufacturing
  • Process engineering
  • Aseptic and sterile processing
  • Quality assurance and quality control
  • Analytical chemistry
  • Bioequivalence evaluations
  • Immunochemistry
  • Microbiology
  • Clinical immunology
  • Statistical analysis
  • Technical writing
  • Software systems engineering, validation and quality.
Collectively, our Associates have worked across the full range of medical products, from novel pharmaceuticals, parenterals and sustained release dosage forms, to sunscreens and other OTC formulations; from Class I Exempt to Class III devices; from simple to complex IVDs; and from low- to high-risk software.

In addition to our in-house staff, AccuReg maintains a network of highly qualified Affiliate Associates with whom we have worked for years. These individuals supplement our core team with additional experience and specialized expertise, allowing us to effectively serve clients with extensive or long-term projects at various locations in and out of the U.S. All of our Affiliates meet the high standards for credentials and experience required of our in-house Associates, and their qualifications are tried and proven before any client assignment is made.

AccuReg takes pride in our team. We believe they are the best professionals in the industry.
  Home | About AccuReg® | Mission | Leadership | Services | Partial List of Clients | Sample Projects | Site Map | Contact Us  
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