Independent GMP Audits & Compliance Support for Regulatory Excellence
QBridge Pharma provides professional GMP Audit & Compliance services to help pharmaceutical companies evaluate their systems, identify gaps and maintain continuous compliance with global regulatory requirements.
Our audits are practical, risk-based and inspection-oriented, ensuring organizations are well-prepared for regulatory inspections and customer audits.
Our GMP Audit Services
We conduct comprehensive audits covering facilities, systems, processes and documentation.
Third Party & Mock Regulatory Audit
- Perform third party audit for API / Excipients / Primary Packaging Materials manufacture / supplier based on customer recommendation. Responsible for audit report preparation, compliance and closure.
- Perform third party audit for contract laboratory. Responsible for audit report preparation, compliance and closure.
- Perform third party audit for bioequivalence site. Responsible for audit report preparation, compliance and closure.
- Perform third party audit prior to execute regulatory submission batches. Responsible for audit report preparation, compliance and closure.
- Perform mock audit at manufacturing site before regulatory inspection. Responsible for audit report preparation, compliance and closure.
Audits and Supplier Qualification
Quality assurance extends beyond your immediate operations. Our consultancy offers comprehensive audits, including Current Manufacturing Unit (CMU) audits, ensuring your manufacturing processes align with current regulations. We now offer specialized supplier qualification services, guaranteeing that your supply chain adheres to the same rigorous quality standards.
Compliance
Our Expertise Team is prepared the compliance for regulatory, local and client wise with respect to proper root cause and corrective action & preventive action with proper documentation.
Key Outcomes for Clients
- Clear visibility of GMP compliance status.
- Reduced regulatory and inspection risks.
- Stronger quality systems and controls.
- Improved audit confidence.
- Sustainable compliance culture.
Be Inspection-Ready with Expert GMP Audits
Partner with QBridge Pharma for reliable GMP audits and compliance support aligned with global regulatory expectations.