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.
Why an experienced SME regulatory consultant is key for non-EU companies
For any non-EU small and medium-sized pharmaceutical company, having a gateway to the European market is crucial. Those companies seeking to take advantage of the European Medicines Agency’s (EMA) SME status will need to work through an EU registered third party, ideally an experienced SME regulatory consultancy. The benefit of having a consultancy for the […]
What is SME Status and how does it benefit innovators?
The European Medicines Agency offers a significant and unique benefit to Small and Medium-Sized Enterprises developing medicines for human or veterinary use. The purpose of SME Status is to promote innovation and the development of new medicines. The SME Regulation, which was established in 2005, led to the creation of the SME office which “provides […]
Data transparency: Why it’s important to post trial results on EudraCT or CTIS
While there is much focus on transparency in the Clinical Trial Regulation, it’s important that sponsors understand their data transparency obligations for trials that were conducted in the EU and that will be wrapped up under the Clinical Trial Directive. Sponsors are expected to ensure results from those studies that do not need to transition […]
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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