Innovative Regulatory Affairs Strategies for Innovative Products

EU/UK Legal Representative Services





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.


INSIGHTS

Pharmaceutical industry knowledge

Blog series: Maintaining Regulatory Momentum in the Covid-19 era: It’s been a difficult year for many biopharma companies and perhaps even more so for clinical research organisations, with Covid-19 forcing the postponement or even cancellation of many if not most clinical trials.  It is however important to keep a finger on the pulse of the […]

Blog series: Maintaining Regulatory Momentum in the Covid-19 era: Preparation for the new regulations  The global disruption caused by the pandemic meant regulatory plans for 2020 needed to be delayed to give the life sciences industry and authorities breathing room. However, it is important to keep up to date with imminent regulatory changes that will […]

Blog series: Maintaining Regulatory Momentum in the Covid-19 era: In early December, the EMA announced that it had been hit by a cyber-attack and that documents related to the Pfizer-BioNTech Covid-19 vaccines had been accessed. The agency issued a brief announcement after the attack to say a full investigation had been launched but provided no […]


London Office

  • 19 Eastbourne Terrace
  • London W2 6LG
  • United Kingdom

Munich Office

  • Albrechtstrasse 43 RG
  • 80636 München
  • Germany


Dublin Office

  • 13 Classon House
  • Dundrum Business Park
  • Dundrum, Dublin D14 W9Y3
  • Republic of Ireland


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