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AccuReg’s Associates are Regulatory Affairs professionals, chemists, engineers, biologists, quality specialists

and technical writers with extensive industrial and regulatory experience, and backgrounds in:


AccuReg Quality Systems, FDA Regulatory & Compliance Consulting
  • Quality systems

  • Regulatory affairs

  • Software systems engineering, validation and quality

  • Research and development

  • Manufacturing

  • Process engineering

  • Aseptic and sterile processing

  • Quality assurance and quality control

  • ISO 13485 Certified auditing

  • GMP and Quality Systems auditing

  • Analytical chemistry

  • Bioequivalence evaluations

  • Immunochemistry

  • Human cells and tissue-based products

  • Microbiology

  • Clinical immunology

  • Clinical trial design / auditing

  • Training

  • Statistical analysis

  • Technical writing

  • Health Insurance Portability and Accountability Act (HIPAA)

AccuReg Quality Systems, FDA Regulatory & Compliance Consulting
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Collectively, our Associates have worked

across the full range of medical products,

from novel biologics, medical devices, HCT/Ps, and pharmaceuticals (including parenterals, and both oral and transdermal sustained release dosage forms), to sunscreens and other OTC formulations; from Class I Exempt to

Class III devices; from simple to complex IVDs; from ANDAs to full NDAs; from Biosimilar to

full Biologics Applications; and from
low-risk to high-risk software.

Our network of highly qualified Associates have a long working history with our firm.

AccuReg takes pride in our team.

We believe they are the best professionals

in the industry.

Many have been with us since

Day One.

Their catalog of specialized expertise

allows us to serve the highly-specific needs

of our clients effectively and with


All our Affiliates meet our highest standards for credentials and experience;

every team member is tried and true, with proven qualifications, before any client assignment is made.

Whether the project is short-term or long-term, within the U.S. or at multiple international locations, AccuReg can assemble the right team to get the job done.

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