We provide innovative solutions

Regulatory Affairs Strategies

for Innovative Products

Get Strategic Advice

EU/UK Legal Representative

Try 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

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.

Pharmaceutical industry knowledge

The answer to medical devices regulatory rigour lies in a well-planned and product-specific strategy

Today’s medical device companies need to think carefully and well in advance about their regulatory and market strategy. Practices that, in the past, would have been acceptable, are no longer adequate in light of tighter regulatory requirements, such as the EU’s Medical Device Regulation (MDR).   This new regulatory environment changes the game in the […]

It’s a new, more costly world for medical devices – preparation is key!

The medical devices and in vitro diagnostics world has changed significantly under much tighter regulations. One standout example is the Medical Devices Regulation (MDR), which was adopted by the European Parliament and the Council in 2017. The Regulation states that medical devices can be placed on the EU market under CE certifications issued until 26 […]

More work, fewer resources and broad uncertainty put pressure on notified bodies

When the Medical Devices Regulation (MDR) came into force, many notified bodies decided not to pursue accreditation. Others are still waiting to get approval. That has meant far fewer notified bodies to perform assessments and more experienced medical device reviewers retiring or moving to industry. The challenge for notified bodies is compounded by the fact […]

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