Quality Management Systems & Compliance Excellence
We support regulatory compliance and responses to observations by USFDA, MHRA, EMA, WHO, TGA, ANVISA & various other health authorities across the globe for drug product.
1. Online Consulting during inspection
2. Online Consulting post-inspection
- Guidance on compliance requirements for each citation (root cause and CAPA)
- Review of responses for completeness and accuracy
3. Proactive assessment of investigations (At site/Virtually)
- Review of Investigation Reports
- Review of deviations, OOS, OOT, complaint investigations, etc.
- Assessment of accuracy, completeness, and regulatory robustness of investigations.
- Provide recommendations to strengthen root cause analysis and CAPA
4. Physical Facility Review and Compliance Guidance
- Pre- or post-inspection facility assessments
- Comprehensive cGMP compliance audit and remediation roadmap
- Guidance for facility and documentation readiness
5. cGMP assessment of Quality Management System (QMS)
- Pharmaceutical Manufacturing Risk Assessment
- Review of cGMP systems
- cGMP audits
- Technical Training
