• Global Audits

GLP Compliance

Laboratories are a key element as part of many USDM audits. These include QC labs, microbiology labs, analytical labs, and many more. GLP compliance is scrutinized by all agencies and USDM has the experts with chemistry, biology and other specific areas of expertise to ensure all items are covered during our audits!

For example, Analytical Method Validation spans all areas of GLP testing, from in-life study tests to HPLC and PK methods. Our staff includes analytical lab expertise in many areas which can provide GLP test method validation support including HPLC, MS, GC, FTIR, UV/VIS and other areas.

Another area of expertise includes Non-clinical GMP facility audits and other aspects of pre-inspection readiness that can include pharmacokinetic datasets which are inspected by a chemical engineer or RN by the FDA.

Other examples include:

  • Laboratory Equipment Qualification
  • Animal testing Facility pre-FDA Inspection Assessment
  • Data Integrity Verification: full raw to final submission-ready data audit
  • PK/PD Data Audit
  • Test Article/Specimen storage
  • Animal Husbandry
  • Records audit: storage, retrieval, retention

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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