August 1 opens regulatory advisory services for inquiries

Developing advanced therapies requires early regulatory clarification. Which legislation should you be aware of? What needs to be in place before a clinical trial can begin? Which authorities need to be involved?

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. In return, we can help you get an overview of the process, identify regulatory topics, prepare important questions, and provide answers to the most common questions, as well as find the right points of contact.

You can, among other things, get help with:
Clarifying regulatory questions in your specific project (e.g., the approval process, requirements, and expectations for documentation).

Which requirements for later commercialization and use in practice should you be aware of already in the early phase

Preparation for dialogue with authorities, including which questions are typically important to clarify early on, and what you can advantageously have ready.

We will do our best to answer your question.

How we can help you move forward
Here you can read more about how to apply for regulatory support: Regulatory support