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
- CRPN Quality Roadmap® Methodology & Hosted Application
- Quality-Pulse.com (Quality Culture Diagnostic)
- Data Integrity
- REMS (Risk Evaluation and Mitigation Strategies)
- Product Quality Consulting
- GMP Consulting Services
- Operational Efficiency / Compliance Effectiveness
- Project / Program Management
Regulatory, Due Diligence & Commercialization
- Product Development / Submissions / Commercialization
- Mergers / Acquisitions / Licensing
Quality, Compliance, Regulatory & Operations’ Staffing Services
- Interim Executive and Expert Placement
- Proprietary, Best-In-Class Approach to Talent Management
- Rapid Request Turnaround of Talent Needs
- GMP Consultants
