From 1 August: Get help with the regulatory landscape
From 1 August, ATMP Denmark offers regulatory support to public and private stakeholders working with ATMPs in Denmark.
What can you expect?
Developing advanced therapies requires early regulatory clarification. What requirements apply? Which authorities need to be involved? What must be in place before a clinical trial can begin?
ATMP Denmark offers non-binding regulatory guidance to public and private stakeholders working on the development of or clinical trials with ATMPs in Denmark.
We are not a regulatory authority and cannot make decisions or assess data. Responsibility lies with the relevant authorities. That said, we can help you gain an overview of the process, identify regulatory topics, and find the right points of contact.
You can get help with:
Clarifying regulatory questions in your specific project (e.g., approval process, requirements, and expectations for documentation).
Which requirements for later commercialization and use must you be aware of already in the early phase.
Preparation for dialogue with authorities, including which questions are important to clarify early on, and what you can advantageously have ready.
We will do our best to answer your questions.
Who can receive regulatory support?
We collaborate with both public and private stakeholders in Denmark—and provide guidance and support regarding ATMP.
Public hospitals
Academic environments
Private companies
Here’s how we can help you move forward
Send an email to regulatorysupport@atmp.dk with a brief description of your project. We will confirm receipt and get back to you with suggestions for the next steps, which may be a short, clarifying meeting or a written summary.
Briefly describe your project, where you are in the process, and what you would like to have clarified with us.
We confirm receipt and will get back to you with suggestions for the next step in the process.