Compliance Architects® Service Offerings

Compliance Architects® – the industry’s best FDA quality consultants – offers a comprehensive suite of professional advisory and consulting services specifically designed and developed to resolve the most challenging FDA compliance issues. The following reflects both general and specific services that can be professionally delivered by Compliance Architects®:

Inspection Readiness
& Enforcement

  • FDA Enforcement (483 & Warning Letter, Etc.) Response / Remediation
  • FDA Inspection Readiness
  • Audits & Assessments
  • Data Integrity

Quality Systems & Training

  • Quality System & Compliance Turnarounds / Restructuring
  • Training / Coaching
  • CGMP Consulting
  • Quality & Compliance Computer-Based Systems
  • External Supply Chain Compliance
  • Part 11 & Computer Systems Validation
  • Turnkey Quality Systems

Corporate Compliance
& Litigation

  • Corporate Compliance
  • Interactions with Department of Justice and the Courts

Quality Assurance & Engineering

Regulatory, Due Diligence & Commercialization

  • Product Development / Submissions / Commercialization
  • Mergers / Acquisitions / Licensing

Quality, Compliance, Regulatory & Operations’ Staffing Services