European Regulatory Services
Providing EU regulatory assessment, strategy, and guidance for market entry
Mapi works with regulatory agencies in over 60 countries, and has submitted over 30,000 regulatory filings since 2006. Our full-service regulatory team consists of 120 consultants and advisors, including regulatory executive and director-level staff members averaging 15-35 years in Full Life Cycle Expertise.
By partnering with the Mapi European regulatory services team, you will leverage our many years of experience working with EU Regulatory Agencies to navigate and expedite your company’s European regulatory affairs program.
Comprehensive Submission Preparation and Publishing Services
- Clinical trial applications (CTAs), CTA substantial amendments
- MAAs- CP, DCP, MRP, national applications including renewals and variations in accordance with CTD, eCTD
- Orphan medicinal product submissions [designations & renewals]
- Post Marketing Maintenance
- Preparation of EU Regulatory Agency pre-meeting packages
- Communication with EU Regulatory Authorities, expert interpretation addressing responses effectively
- Regulatory CMC consulting services
- Regulatory Intelligence: information, analysis, and strategy
- Literature searches
- Strategic Development Consulting
- Due Diligence
Let Mapi be your integrated regulatory solution for European submissions.
- Experts that will clarify and negotiate the regulatory path for pharmaceuticals and biologics
- Specialist who can prepare and file submissions effectively
- Problem-solving to achieve and maintain compliance at any stage of the product lifecycle