Using a risk-based compliance audit approach, Regulatory Compliance Associates® Inc. will help your company identify and correct deficiencies and choose 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 Analysis
  • Combination Products
  • 503A and 503B Compounding
  • Development of Inspection Checklists
  • Quality System Compliance Audit
  • Internal Audits
  • Contract Manufacturer Audits
  • Supplier Audits
  • Virtual Audits


About RCA

Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

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