Smiling businessman sitting with a diverse group of coworkers during a meeting together at a table in an office

EU Regulatory Submissions

Unlock the potential of the European market with our dedicated support for Marketing Authorisation Applications (MAA), Clinical Trial Applications (CTA), and Orphan Drug Designation Applications.

Whether pursuing centralised or decentralised approvals, our team is well-versed in the nuances of the European Medicines Agency (EMA) processes. Post-approval, we provide vigilant compliance support, managing variations and renewal applications to uphold marketing authorisation.

Young designer giving some new ideas about project to his partners in conference room. Business people discussing over new business project in office.

Trusted by top-tier teams worldwide

DSC_1343

Marketing Authorisation Applications (MAA):

  • End-to-end submission support
  • Oral Explanation and CHMP meeting preparation

Clinical Trial Applications (CTA):

  • CTA submissions across EU member states and centralised routes
  • Regulatory query and protocol amendment support

Orphan Drug Designation Applications:

  • Clinical trial design optimisation
  • Post-approval orphan status maintenance

Post-Marketing Regulatory Compliance:

  • Managing variations and PSURs
  • Renewal applications and compliance checks

FAQs

We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.

Here are some of the questions we get asked most often.

What experience do you have with ATMP clinical development?

Our team has extensive experience in Advanced Therapy Medicinal Product (ATMP) clinical development and is well-versed in how to deliver compliance throughout the development process. Get in touch with us for further information. 

Can you offer support in developing a clinical strategy at an early stage?
Which countries can you help cover in terms of licence management?
Do Apotech provide Qualified Person (QP) and Responsible Person (RP) services?

Featured case studies

Sorry, we couldn't find any posts. Please try a different search.

View all case studies

Ready to get started?