Expert GMP Consulting for Regulatory Compliance & Inspection Readiness
QBridge Pharma provides specialized GMP Consultancy services to help pharmaceutical companies establish, maintain and improve GMP-compliant systems and facilities. We support organizations in meeting global regulatory expectations, ensuring inspection readiness and achieving sustainable compliance.
Our consultancy approach is risk-based, practical, and aligned with WHO-GMP, EU-GMP, PICs and other international guidelines.
Our GMP Consultancy Services
We offer end-to-end GMP consulting support across the product and facility lifecycle.
GMP Gap Analysis
- Complete Gap Analysis in the aspect of QMS and Facility to meet Regulatory expectation.
- Guidance to comply the deficiencies outcome during gap analysis.
Quality Management System (QMS) Support
- Guidance to trigger inspection (WHO / EU-GMP / PICs / TGA / Ethiopia / Uganda / Kenya / Zimbabwe / Ghana / Tanzania / Philippines / Vietnam / Other ROW Market) at site.
- Guidance for Application filling to health authority.
- Guidance for site and technology transfer project.
Regulatory Inspection Support
- Guidance for PLC / ERP / SAP system validation.
- Arrange mock up audit from EU- QP prior to regulatory inspection or after registration of the products.
- Guidance for site variation filling.
CAPA & Compliance Management
- Guidance for preparation of CAPA in the aspect of received deficiency from agency and customer.
- Guidance for equipment /instrument Qualification as per 21 CFR compliance/Annexure -11.
- Guidance of Process Validation as per Annexure-15.
- Guidance of established the Quality Management System to meet international regulatory requirements.
Key Benefits for Clients
- Improved GMP compliance and system robustness
- Reduced inspection and regulatory risks
- Confident regulatory interactions
- Faster approvals and smoother audits
- Long-term compliance sustainability
Strengthen Your GMP Compliance with Expert Support
Partner with QBridge Pharma to build robust GMP systems and achieve regulatory success.