Compliance Insight is a trusted partner in the life sciences industry. We focus on helping life science businesses develop products safely and confidently deliver them to consumers. We are committed to providing the highest quality services for companies in the pharmaceutical, medical device, supplement, and biologic markets while also ensuring FDA Compliance. Rather than simply take a product by product approach to FDA compliance, we strive to help our partners implement foundational solutions that set new standards for quality, safety and productivity. As a partner with Humphrey Regulatory, we offer the following assistance

  1. Training Power-Point: Good Clinical Practice Training/FDA Inspections/Role of the Principal Investigator/Role of the Institutional Review Board/Ethics/Notes to File/Clinical Trials Gone Awry
  2. Audits of Institutional Review Board per CP 7348.809 and 21 CFR 56
  3. Audits of Clinical Sites per CP7348.811
  4. Audits of CRO’s/Sponsors per CP 7348.810
  5. Phase I audits and preliminary reviews of Phase I prior to study appointment
  6. Response to FDA-483’s and Warning Letters
  7. Vendor Audits/First Responders/Hospital Emergency Rooms near Phase I etc.…
  8. Radioactive Drug Research Committees……………usually found at Medical School Institutions i.e.…University of Kentucky and University of Louisville.
  9. SOP Review