Audit Services

If you'd like to know where you stand with the FDA, MHRA, EMA before they perform an inspection, or if you have an issue with any of their regulations we can perform an audit of your operations. Our team of Compliance consultants includes employees with decades of experience as well as industry experts and subject matter experts. By the time we've finished an audit, you'll know where you're at, where you need to be, and how to get there. We can audit specific areas of your operation or provide a comprehensive review of your entire system. We'll audit against current FDA/MHRA/EMA regulations and provide gap analysis, including how to correct gaps. 

In addition to auditing your plant or facility, we can also perform the following audits on third party facilities, vendors / suppliers, and contract manufacturers and laboratories:

  • GMP audits (Good Manufacturing Practice)
  • Lab SOP audits (Standard Operating Procedures)
  • 21 CFR part 820 audits
  • 21 CFR Parts 210 and 211 audits
  • 21 CFR Part 111 audits
  • QC / QA (Quality Control) audits

Our audits extend to all FDA regulated industries, including:

  • Dietary Supplements
  • Drugs/Pharmaceuticals
  • Medical Devices
  • Food and Tobacco
  • Clinical Trials

Contact Us

For more information about our audit services, please email at