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GMP Audit & Gap Analysis Assessments

FDA, EU, ISO, Vendors & Supplier GMP QMS Audits, Full Gap Analysis, Training & Remediation Services

  • ​​GMP Audits - Drugs, APIs, Excipients & DEA

  • Combination Device - Part 820 QSR / 21 CFR Part 211

  • Vendor - Supplier Audits, CMOs, CDMOs, CRO, CPO

  • Laboratory Audits - GLP/GCLP - Part 58/OECD

  • Company Acquisitions & Compliance Audits

  • Mock FDA, EU, NMPA & WHO Audits

Mock FDA - PAI - Supplier Audits

Remediation & Gap Analysis:

  • 483 Help!  EIR 483 and Warning Letters - Compliance

  • Gap Analysis Support & Turn-Key GMP / Turn-Key GMP​​

  • 503b Outsourced GMP Facility Qualifications

  • Standard Operating Procedure Turn-key Development

  • Validation Audits / Writing - Process & Equipment

  • Remediation, Validation & Gap Analysis Report

  • As-Built Drawing Qualifications & Validation

  • Engineering GMP Evaluation & Analysis Services

  • DEA Controls - Facility Qualifications

  • Facility & Site Qualification Services - BOD Development

GMP Audits the Regulations
GMP Knows the Regulations!
21 CFR Mini-Regulation Handbooks supporting U.S. FDA and International Regulations and Guidance
GMP Publications FDA Regulation and Guidance Handbooks
Retail Good Manufacturing Practice GMP Certificate Program
Supplier GMP Certificate Program for the Retail Market
  • Dietary Supplements & Vitamins

  • Cosmetics & Topicals

  • Protein & Nutrient Bars and Drinks

GMP Certificates supporting your Product Quality & GMP Compliance!
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