Noticias
25 septiembre 2026
Accelerate Your Journey to EU Approval
Integrated regulatory, analytical, and GMP services to help Non-European pharmaceutical manufacturers obtaining Marketing Authorization from EU health agencies and to release batches in commercial production.
Bringing a drug product to the European market requires navigating a complex regulatory landscape. SOTAX helps pharmaceutical companies - especially those based outside the European Union - bring drug products to the EU market, perform routine testing, and maintain commercial compliance.
Three connected Pharma Services packages cover the entire market-entry lifecycle:
Marketing Authorization Application (MAA)
- Regulatory Strategy: Determining whether a national route (e.g., Germay via BfArM) or a centralized EU route (via EMA) is optimal
- CTD & Module 3 Development: Supporting CMC (Chemistry, Manufacturing, and Controls), quality controls, analytical method development, transfer, validation, and stability testing
- Dossier Compilation & Review: Conducting gap analysis to reduce agency review cycles, finalizing eCTD submissions, and assisting with agency responses
Routine Testing & EU Batch Release
- EU-based GMP laboratory: Analytical testing performed at SOTAX's GMP facility in Orleans, France (providing the necessary EU footprint)
- Import & QP Release: Sample import coordination, testing, and Qualified Person (QP) release support (e.g. German QP for national registrations or EU-wide QP release)
- Manufacturing Site Support: GMP inspection readiness and review of customer manufacturing facilities
Post-Approval Support
- Managing post-approval variations, variations documentation, and ongoing compliance obligations
- Supporting Marketing Authorization renewals (typically every 5 years)
Learn how SOTAX Pharma Services can support your EU registration strategy and market launch.