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EU Regulatory Submissions

Q: Can you offer support in developing a clinical strategy at an early stage?

Yes! We can support you in developing clinical strategies at whatever stage they’re currently at. By working with you, we can craft tailored strategies that align with your regulatory expectations and maximise the potential for successful clinical trials.

Q: Which countries can you help cover in terms of licence management?

Our services can be tailored to your specific requirement to offer support in a wide variety of different countries and markets around the world, including the UK, EU and US.

Q: Do Apotech provide Qualified Person (QP) and Responsible Person (RP) services?

Yes, we offer Qualified Person (QP) and Responsible Person (RP) services and have the expertise required to ensure compliance with regulatory requirements. Check out our QA services page.

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.

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FAQs on Regulatory affairs

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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.

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

Global in-country regulatory support

510(k) Submission Introduction Top 3 Global CRO Our client is one of the largest CROs globally, with operations present in every economy. Their services range from Clinical Development, Medical Affairs, and Commercial Delivery. Apotech continues to partner with them on a 3-year FSP contract. Apotech’s Consultants Our 18 strong Consulting team includes a mixture of…

Borderline device classification

Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and wellness product manufacturer identified revenue opportunities marketing their cosmetics devices with increase claims. Apotech was engaged to perform a blanket regulatory assessment of cosmetic devices and provide judgement and pathways for market authorisation as a medical device…

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