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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

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

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.

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 […]

Liability or life-saving: The risks associated with IVDs in personalised medicine

Over the past 10 to 15 years, there has been a steady trend towards personalised medicine, particularly in the field of oncology. This has led to increased use of in vitro diagnostic products, or investigational IVDs, to determine the right medicine for the patient. It is worth noting that personalised medicine is not a new […]

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