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About AccuReg® |
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 AccuReg 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. |
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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. |
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|
Home |
About AccuReg® |
Mission |
Leadership |
Service Overview |
Partial List of Clients |
Sample Projects |
Site Map |
Contact Us |
|
|
|
|
|