Compliance & Regulatory Support Services in All GxP Environments
Audits
- Mock-FDA Audits & Inspection Readiness - Ensure you can conduct a true mock-FDA audit by using the services of a former FDA Investigator and/or product reviewer. You can expect an FDA inspectional approach.
- GAP Analysis
- Compliance Assessments
- Quality Systems
- Data Integrity Audits & Reviews
- Part 11 Compliance
- PAI- Readiness for commercial manufacture
- Supplier/Vendor Qualifications
- Due Diligence - Minimize your risk and contact us to participate in your due diligence audit.
- Phase-Appropriate GMP and Commercial Readiness Audits
- Directed or For-Cause Audits
- cGMP, cGTP, cGCP, QSR
CAPA Remediation
Support for CAPA investigation review and effectiveness review, compliance plans, FDA-483 remediation, and written response, Warning Letter remediation and written response.
In-House Quality Assurance Services
Our consultants have been engaged to provide rotational onsite Quality Assurance Systems support, in the absence of permanent quality personnel. Contact us to discuss options for temporary staffing.
FDA Inspection Support
Consultants can provide onsite support during regulatory inspections, assist in back-room management, and provide inspection preparedness training.
FDA Meeting Preparation & Engagement
Our consultants will provide regulatory meeting support prior to, during, and after regulatory meetings.
Training
Our consultants have provided onsite quality and compliance training worldwide. Contact us to discuss your training needs.
Regulatory Strategy
Strategic planning to navigate the FDA regulatory landscape. Our direct FDA experience can facilitate a smooth process and regulatory path forward.
FDA Meeting Preparation & Engagement
- Our consultants will review and assess FDA correspondance and will assist in response preparation.
- Our consultants will provide support prior to, during, and after FDA regulatory meetings.