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.
The biggest mistakes when applying for clinical trial approval in the EU for a rare disease
In the field of rare disease innovation, there has been a tendency to put off planning for the EU, perhaps due to concerns over the requirements or uncertainty as to how to navigate its complex, multi-national landscape. This has, unfortunately, led many sponsors to see “Europe as a problem for later” (or “a problem for […]
Comparing rare disease applications in the EU and the US
Innovators from markets outside the EU often have many questions about what to expect with the European Medicines Agency (EMA). For US sponsors with rare disease products, both significant and subtle differences can be a minefield when seeking EMA approval. 1. Navigating 27 markets and standards of care First and foremost, while there have been […]
Sampling the buffet of scientific advice with rare disease product development
Sponsors of products for rare diseases must manage a complex environment and often in a much shorter timeframe to meet high unmet need. However, they have one significant advantage: access to free scientific advice from the European Medicines Agency (EMA). Orphan Drug Designation, the PRIME (PRIority MEdicines) scheme, conditional marketing approval – these and other […]
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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