The European Union's Good Manufacturing Practice (EU GMP) framework governs the manufacture of medicinal products sold within the EU. Compliance with EU GMP is mandatory for any pharmaceutical company seeking to manufacture, import, or distribute medicines in European markets. RBridge Lifesciences provides comprehensive EU GMP consulting services — from gap assessment and dossier preparation through to QP audit support and market approval.
What We Offer
- Gap Assessment and End-to-End Preparation of Dossier
- Dossier Preparation, Review, and GAP Analysis
- Dossier Submission Assistance and DCP Slot Booking
- EU QP Audit and Batch Release Support
- Product Licence and Market Approval
- Agency Liaisoning and Inspection Management
- GMP Compliance, Upgradation, and Renewal
Why EU GMP Compliance Matters
- Mandatory for any product sold or manufactured within the European Economic Area
- Covers all stages of production: starting materials, intermediates, finished products
- Inspections conducted by national competent authorities (NCAs) on behalf of EMA
- Non-compliance can result in import alerts, product recalls, or market withdrawal
- Regular updates via EudraLex Volume 4 and associated annexes require ongoing vigilance