Using a risk-based approach, Regulatory Compliance Associates® Inc. will help your company identify and correct compliance deficiencies and choose the best solutions to determine readiness for inspection.

 

ASQ-CQA or Exemplar Global certified auditors are available for the following:

 

  • Supplier Audits
  • Current Good Manufacturing Practices (cGMP) Compliance Audits: Manufacturing, Pilot Plant, Laboratory Facilities
  • Current Good Laboratory Practices (cGLP) / cGMP Compliance Audits
  • Regulatory Gap Analyses
  • Risk Assessments
  • Pre-Approval Audits
  • CFR Part 11 Gap Analysis
  • Development of Inspection Checklists
  • Quality Systems
    • 820 Audits
    • ISO 13485 Audits
  • Internal Audits
  • Contract Manufacturer Audits
  • Supplier Audits

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