Overview:
The regulatory system for medicinal products in Europe is one of the most complex globally. With varying national requirements and procedures, it presents both challenges and opportunities—especially for manufacturers aiming to enter the European market. Our expert-led regulatory support helps pharmaceutical companies seamlessly navigate every step of the compliance journey.
Our Comprehensive Support Approach
End-to-End Regulatory Guidance
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Strategic Planning – Regulatory roadmaps tailored to your product and target markets
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Dossier Preparation & Submission – Fully compliant documentation aligned with EMA or national agency standards
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Marketing Authorization Pathways – Expertise across Centralized, Decentralized, MRP, and National Procedures
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Post-Approval Compliance – Lifecycle management, updates, labeling, and regulatory changes
Why Choose the Centralized Procedure?
For companies aiming for pan-European access, the Centralized Procedure—coordinated by the European Medicines Agency (EMA)—offers a streamlined route. One application leads to authorization in all EU member states, reducing time-to-market and duplication.
Key Benefits (Icons or Bullet Points):
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Single marketing authorization
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EMA oversight ensures harmonized evaluation
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Faster access across all EU countries
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Duplicate authorizations possible in certain cases
Regulatory Maintenance & Risk Management
Regulatory compliance doesn’t end with marketing authorization. We provide continuous support to manage updates, respond to inspections, and handle recalls or regulatory changes. Our proactive compliance solutions ensure your products remain legally marketed without interruption.
Our Expertise
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Strategic Regulatory Consulting
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Regulatory Roadmaps for Market Access
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Regulatory Affairs & Intelligence
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Dossier Management & Publishing
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End-to-End Submission Handling
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Pharmacovigilance (PV) Services
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In-country Regulatory Representation
Our Comprehensive Support Approach
Our Comprehensive Support Approach
