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Passionate about
your product

IDEA is passionate about getting innovative products to patients with unmet needs and we particularly enjoy putting our full weight of innovative thinking and regulatory expertise behind innovative medicine.

Helping you to help
patients

Our goal is to attain the best possible results for patients, by understanding the goals of our clients, cooperating with authorities, and utilising available regulatory incentives to accelerate assessment, while delivering quality data for regulatory approval.

Working as part of
your team

We work as part of your team and are fully with you on your regulatory journey, helping to navigate the complex and ever-evolving global regulatory and market access environments, pre-empting and managing the common misunderstandings that can cause you unexpected costs and delays.

Quality and
Pragmatism

By harmonising pharmaceutical Quality By Design principles with your business goals, we deliver dynamic regulatory strategies to help you recognise your product’s full potential. Avenues of communication will always be clear, helpful, easy and proportionate.

Allowing time for the legal rep evaluation in the move to CTR

The Clinical Trials Regulation (CTR) has added some complexities for non-EU sponsors, including with regard to the role of the legal representative. Sponsors who are not based in the EU must appoint a representative within the EU to act as a legal representative. While this has always been a requirement, under the CTR the legal […]

Understanding what’s required to work in CTIS

Before making a submission to the CTIS, sponsors transitioning clinical trials previously approved under the EU Clinical Trials Directive must take several preparatory steps. These can be time consuming and are not always well-understood so it’s important that you take time to prepare yourself before making the transition. To get started, you will need to […]

The multiple steps involved in the transition to CTR

There is a lot for sponsors to think about before they can even start transitioning their clinical trials to the Clinical Trial Regulation (CTR) and accessing the various portals. First, there are practicalities of how they will manage their ongoing studies to ensure they are suitable to transition to CTR. While this is something most […]

London Office

  • Metal Box Factory
  • 30 Great Guildford Street
  • Borough
  • SE1 0HS
  • United Kingdom
+44 (0) 20 392 10201 info@IDEAregulatory.com

Munich Office

  • Albrechtstrasse 43 RG
  • 80636 München
  • Germany
+49 (0)30 4036369-20 info@IDEAregulatory.com

Dublin Office

  • 13 Classon House
  • Dundrum Business Park
  • Dundrum, Dublin D14 W9Y3
  • Republic of Ireland
+353 (0) 15394365 extension 1008 info@IDEAregulatory.com