Auditing and Validation


Experienced in auditing of Manufacturing Facilities,

Laboratories, Packaging, and Label Operations utilizing

GxP, CAP and CLIA Regulations, as Requested by Client.


  • Vendor/Contractor/Partner Audits:  21 CFR Part 820, IVDD (98/79/EC), MDD, Client Specified Regulations and SOP's 
  • Client Internal Audits: 21 CFR Part 820, IVDD (98/79/EC), MDD, Client Specified Regulations and SOP's
  • FDA and EU Labeling Compliance Assessment
  • Facilities, Equipment, and Computer Validation Support and Coordination
  • Due Diligence Investigation of Potential Partner Companies/Contract Vendors