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.
Reviving Clinical Research: The UK CTR and a New Era for Innovation
The UK’s Clinical Trials Regulation (CTR), signed into law in April 2025, aims to foster innovation, accelerate approvals, and enable patient participation in research while safeguarding their safety and rights. Supporting innovation is a key priority for the Medicines and Healthcare products Regulatory Agency (MHRA), particularly as the UK has experienced a steady decline in […]
What is PRIME? Understanding the EMA’s early support for promising medicines
Addressing unmet medical need is a key priority for the European Medicines Agency (EMA). In response to this, the agency launched the Priority Medicines scheme in 2016. Its core aim, and its appeal for developers, is to offer early and enhanced regulatory support to accelerate the development of potentially transformative medicines. Key features of PRIME […]
Why a proper understanding of PRIME is key to a successful regulatory journey
The tailored scientific advice and regulatory guidance offered through EMA’s PRIME scheme are a major draw for sponsors. While it is often assumed that PRIME is focussed on rare diseases, that is not necessarily the case. Sponsors developing products identified by EMA as public health priorities may be eligible. These include treatments for antimicrobial resistance […]
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London Office
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- 19 Eastbourne Terrace
- London
- W2 6LG
- 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