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.
Understanding what the PIP development plan entails
During our conversations with clients from the United States, we often find there is a misunderstanding about the paediatric investigation plan (PIP). Many see the PIP as simply a document that is part of the clinical trial application process or marketing authorisation application interactions with the European Medicines Agency (EMA). This confusion stems from the […]
How sponsors of orphan drugs can take advantage of paediatric expertise at the PDCO
Rare diseases raise a critical planning consideration for sponsors: how to manage the inclusion of a paediatric population. This can be particularly challenging due to factors such as limited patient numbers, ethical considerations in trial design for children, and the need for age-appropriate formulations. Around 75% of rare diseases largely affect a paediatric population, which […]
What is the right EMA initiative for your innovative medicine development programme?
Developers looking to bring their products to the European Union are often unaware of the different pathways open to them to get regulatory support. The European Medicines Agency (EMA) offers several initiatives to support innovators. However, there is some nuance to understanding which of these might be right for a developer, and at what stage […]
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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