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. We will work with your personnel to help get them ready for inspections.

 

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

 

  • Document Control Systems Implementation and Remediation
  • Supplier Audits
  • Current Good Manufacturing Practice (cGMP) Compliance Audits: Manufacturing, Pilot Plant, Laboratory Facilities
  • Current Good Laboratory Practices (cGLP) Compliance Audits
  • Good Clinical Practices (GCP)
  • Regulatory Gap Analyses
  • Risk Assessment
  • Pre-Approval Audits
  • 21 CFR Part 11 Gap Analysis
  • Software
  • Combination Products
  • 503A and 503B Compounding
  • Development of Inspection Checklists

 

  • Quality System Audits
  • Internal Audits
  • Contract Manufacturer Audits
  • Supplier Audits

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