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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

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GMP Audits the Regulations
GMP Knows the Regulations!
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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