Innovative Regulatory Affairs Strategies for Innovative Products

EU/UK Legal Representative Services

Our solutions

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.

Pharmaceutical industry knowledge

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Report study results or face a big stick: the pros of regulatory penalties

Reporting your clinical trial results is both a legal requirement and a moral imperative. Whether your product failed early on, failed in later-stage trials, or was successful, the data from those trials could be transformational. Until recently, though, companies faced few consequences if they didn’t report their results. In April 2021, the FDA threatened to […]

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The Importance of QMS and Vendor Oversight for Non-EU Sponsors Under The CTR

Good clinical practice is well-entrenched in global biopharmaceutical companies, and almost every sponsor company adheres to the Declaration of Helsinki with regards to following ethical principles in their medical research. For US companies, the standards established by the Food and Drug Administration (FDA) are very much in line with what is required in the European […]

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Independent Oversight: Why It’s a Risk to Have Your CRO as Your Legal Representative

In theory, there is no reason and nothing in the Clinical Trial Regulation (CTR) that prevents a contract research organisation (CRO) being named as the EU Legal Representative by a Sponsor. However, it does beg the question as to whether there would be a conflict of interest, since what it means is the sponsor is […]

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