Innovative Drug European Associates


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

May 24, 2019by admin

FAO: ALL UK-BASED SPONSORS OF EU CLINICAL TRIALS If you are a UK-based sponsor with a clinical trial in the rest of the EU, Brexit could have a profound impact on the legal status of your study. Clinical trials in the EU are governed by the Clinical Trials Directive 2001/20/EC. According to Article 19 of […]

May 8, 2018by admin

When the Medical Device Regulation (MDR) and In-Vitro Diagnostic Device Regulation (IVDR) transition was launched earlier this year, medical device manufacturers were faced with a steep mountain of regulatory, legal, process and resource challenges that would need to be climbed in order to introduce new and continue supplying existing devices for use in healthcare. In […]


London Office

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

Munich Office

  • Machtlfinger Strasse 13
  • 81379 Munich
  • Germany


Dublin Office

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


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