SUPPORTING CLINICAL TRIALS AND ORPHAN DRUG DEVELOPERS WITH REGULATORY AFFAIRS AND EU LEGAL REPRESENTATION





Supporting Orphan Drug Developers


IDEA is as passionate as you about your product. We understand the art and science of regulatory approval, and can help you devise a regulatory and reimbursement strategy that could be the critical difference in ensuring your product reaches as many of the needs of patients as possible across the globe.



Supporting Clinical Trials


IDEA understands the needs to today’s busy clinicians. We understand that you want to focus your efforts where it really matters – on making a difference for your patients. But running trials of innovative new treatments with the needs of patients, collating strong data and publishing results needs a solid regulatory framework.



Supporting Product Value


Bringing new medicines to market is a challenge, both scientifically and financially. IDEA
understands the challenges faced by entrepreneurs to maintain a constant investment stream whilst keeping a keen eye on developments in the market for your target indications.



Supporting CRO’s in Accessing Europe


European regulatory systems are complex and highly demanding. For CRO’s, especially those outside Europe, navigating the complex country-specific legal and regulatory requirements is a significant challenge. IDEA is able to provide EU legal representation and regulatory assistance to help CROs understand how to maximise access.


INSIGHTS

Pharmaceutical industry knowledge

Despite having talented teams, small companies are forced to work with limited resources and access to specific expertise. They often lack the resources and experience in navigating specific regulations, the nuances of working in different countries and have limited time to spend on regulatory intelligence. Working with a regulatory expert who is familiar with your […]

The global coronavirus pandemic, or COVID-19, has brought about both a health crisis as well as personal and business uncertainty. Yet bringing new life saving and life changing products to market remains a pressing priority. Patients are waiting for cures and their needs cannot be postponed. As a leader in providing regulatory affairs expertise and […]

Developers of orphan drug products face some important changes with the approval process in the UK after Brexit. To help companies prepare, the MHRA published new guidance: “How the MHRA will manage orphan medicinal products from 1 January 2021 in Great Britain (GB)”. While most of the criteria to qualify for orphan drug designation align […]


London Office

  • 19 Eastbourne Terrace
  • London W2 6LG
  • United Kingdom

Munich Office

  • Albrechtstrasse 43 RG
  • 80636 München
  • Germany


Dublin Office

  • 13 Classon House
  • Dundrum Business Park
  • Dundrum, Dublin D14 W9Y3
  • Republic of Ireland


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