A Qualified Person (QP) plays a critical role in ensuring that medicinal products released to the European market comply with EU GMP requirements and marketing authorizations. Our Qualified Person (QP) Support services provide pharmaceutical and life sciences organizations with expert oversight, regulatory assurance, and compliant batch certification support aligned with EU regulatory expectations.
We help organizations meet EU GMP release obligations, strengthen quality systems, and maintain uninterrupted market supply.
Comprehensive QP Support Solutions
Our QP services are designed to support manufacturers, importers, and MA holders with both routine operations and regulatory-critical activities.
Scope of Qualified Person (QP) Support
- QP Batch Certification & Release Support
- Review and certification of batches for EU market release
- Verification of compliance with EU GMP and Marketing Authorization
- Review of batch documentation and release records
- Support for importation and third-country manufacturing sites
- EU GMP Compliance Oversight
- Oversight of GMP compliance at manufacturing and testing sites
- Review of Quality Management System (QMS) effectiveness
- Evaluation of deviations, OOS, and CAPA impact on batch release
- Change control assessment from a QP perspective
- Audit & Inspection Support
- Participation in internal and external GMP audits
- Supplier and contract manufacturer audit review
- Support during EU regulatory inspections
- Inspection readiness and post-inspection follow-up
- Regulatory & Documentation Review
- Review of Site Master File (SMF) and quality documentation
- Alignment with EU GMP, ICH Q7, and Ph. Eur. requirements
- Assessment of validation, qualification, and data integrity status
- Documentation support for EDQM, MAH, and EU submissions
- Ongoing QP Advisory & Compliance Support
- Continuous QP advisory services
- Risk-based compliance guidance
- Support for variations, renewals, and regulatory commitments
- Business continuity and supply chain assurance
Regulatory Standards & Guidelines Covered
Our QP support services are aligned with:
- EU GMP (EudraLex Volume 4)
- Annex 16 – Certification by a Qualified Person
- ICH Q7, Q9, Q10
- European Pharmacopoeia (Ph. Eur.)
- EDQM & EMA Expectations
This ensures products released under QP oversight meet EU regulatory requirements.
Risk-Based & Independent QP Approach
We apply a risk-based and independent QP oversight approach, focusing on patient safety, product quality, and regulatory compliance. Our methodology ensures that batch certification decisions are defensible, traceable, and inspection-ready.
Key Deliverables
- QP batch certification and release documentation
- Compliance assessment and risk evaluation reports
- Audit and inspection readiness inputs
- Regulatory-compliant documentation reviews
- Ongoing QP advisory records
Why Choose Our Qualified Person (QP) Support Services?
- EU GMP & Annex 16 Expertise
Strong understanding of QP roles and EU regulatory expectations. - Independent & Objective Oversight
Unbiased batch release and compliance decisions. - Seamless Integration with Operations
Works alongside QA, regulatory, and manufacturing teams. - Reduced Compliance & Supply Risk
Ensures uninterrupted EU market supply. - End-to-End Regulatory Alignment
Integrated with EDQM, DMF, audit, and compliance services.
Industries We Support
- Pharmaceutical Formulation Manufacturers
- API & Intermediate Manufacturers
- EU Importers and Marketing Authorization Holders (MAHs)
- Contract Manufacturing Organizations (CMOs)
- Export-Oriented Pharmaceutical Companies
Release with Confidence. Comply with Assurance.
With stringent EU regulatory expectations and increasing inspection scrutiny, reliable Qualified Person (QP) Support is essential for successful market access and continuity. Our structured and regulator-aligned approach ensures compliant batch release, strong oversight, and regulatory confidence.
Certify responsibly. Release confidently. Comply with EU standards.
