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.
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 […]
Key steps to proper management of CMC with rare disease products
Meeting requirements for Chemistry, Manufacturing and Control (CMC) is complex for any drug developer, but is even more so in the rare disease space. These challenges are further compounded for non-EU sponsors seeking to initiate clinical trials in Europe where the differences in requirements and expectations from their home market are often not well-understood. Manoeuvring […]
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 […]
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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