Regulatory compliance is an ongoing obligation for any pharmaceutical manufacturer or marketing authorisation holder. Health authorities across the globe conduct inspections, and non-compliance can result in warning letters, import alerts, or market withdrawal. RBridge Lifesciences provides proactive compliance assessment and support to help you stay ahead of regulatory expectations.
What We Offer
- Regulatory Compliance Assessment and Gap Analysis
- Pre-inspection Readiness Reviews
- Response Preparation for Regulatory Observations
- CAPA Development and Implementation Support
- Compliance Training for Regulatory and Quality Teams
- Post-inspection Follow-up and Closure Support
Compliance Frameworks Covered
- US 21 CFR Parts 210, 211, and 820
- EU GMP (EudraLex Volume 4) and all Annexes
- WHO GMP Guidelines
- PIC/S GMP Guide
- CDSCO Schedule M (India)
- ICH Q7, Q8, Q9, Q10, Q11 guidelines