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

• 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)

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 l

ow-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.