AccuReg’s Associates are Regulatory Affairs professionals, chemists, engineers, biologists, quality specialists
and technical writers with extensive industrial and regulatory experience, and backgrounds in:
OUR ASSOCIATES

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Quality systems
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Regulatory affairs
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Software systems engineering, validation and quality
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Research and development
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Manufacturing
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Process engineering
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Aseptic and sterile processing
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Quality assurance and quality control
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ISO 13485 Certified auditing
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GMP and Quality Systems auditing
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Analytical chemistry
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Bioequivalence evaluations
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Immunochemistry
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Human cells and tissue-based products
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Microbiology
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Clinical immunology
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Clinical trial design / auditing
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Training
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Statistical analysis
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Technical writing
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Health Insurance Portability and Accountability Act (HIPAA)

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.
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
cost-efficiency.
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.