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.
Trusted by top-tier teams worldwide
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.
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.
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510(k) Submission
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