Innovative Regulatory Affairs Strategies for Innovative Products
EU/UK Legal Representative Services
Our solutions
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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.
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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.
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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.
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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
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 […]
Why navigating the MDR is creating uncertainty for many smaller manufacturers
The Medical Devices Regulation has created some turmoil for manufacturers, particularly smaller companies, as they try to navigate a host of new requirements. Devices that previously would not have had to undergo conformity assessments with the notified bodies may now be classed differently and require assessment. That adds an extra layer of cost and complexity, […]
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London Office
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- Metal Box Factory
- 30 Great Guildford Street
- Borough
- SE1 0HS
- United Kingdom
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Munich Office
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- Albrechtstrasse 43 RG
- 80636 München
- Germany
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Dublin Office
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- 13 Classon House
- Dundrum Business Park
- Dundrum, Dublin D14 W9Y3
- Republic of Ireland
