Compliance Architects® Service Offerings

Compliance Architects® 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

Quality Systems & Training

  • Quality System & Compliance Turnarounds / Restructuring
  • Training / Coaching
  • 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

  • CRPN Quality Roadmap™ Methodology & Hosted Application
  • Product Quality Consulting
  • Operational Efficiency / Compliance Effectiveness
  • Project / Program Management

Regulatory, Due Diligence & Commercialization

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

Quality, Compliance, Regulatory & Operations’ Staffing Services

  • Proprietary, Best-In-Class Approach to Talent Management
  • Rapid Request Turnaround of Talent Needs