Innovative Drug European Associates


Solutions




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 needy patients as possible across the globe.

As a boutique agency, we’re in it for the long haul – we understand that you want your product to receive the best possible fostering by a respected, skilled and experienced team, and not merely be passed onto a junior in an agency that considers its fees first, and your product second.

IDEA is experienced at successfully navigating the pathways to regulatory approval.  With the right contacts, EU legal representation, and regulatory strategy and submission experience, we can help guide and position your product to maximize its reach in Europe and beyond.

We provide critical support to orphan drug developers to assist them in :

  • European regulatory and access strategy
  • European regulatory submissions
  • Specialist support in accessing European markets for non-European based organisations
  • EU Legal Representation
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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 needy patients, collating strong data and publishing results needs a solid regulatory framework.

IDEA removes the burden of the regulatory process and provides clinicians with a solid foundation on which to conduct clinical trials, safe in the knowledge that your published work will be valid and respected.

IDEA provides robust legal representation and regulatory support to clinicians, helping you safely navigate the complex regulatory environment so that you can bring the miracle of modern treatments to your patients faster.

We provide critical support to clinicians seeking to run and publish the results of clinical trials in Europe:

  • European regulatory and clinical trial strategy
  • European regulatory submissions
  • EU Legal Representation
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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.

We understand that strong regulatory and reimbursement strategies can yield considerable benefits in securing future funding. IDEA can help your organisation plan and execute a regulatory strategy designed to help you assess the true potential value of your products, demonstrate your understanding of the market, while providing the backing of a respected name in the critical area of regulatory affairs.

We provide:

  • European regulatory and clinical trial strategy
  • Market shaping and insights
  • European regulatory submissions
  • EU Legal Representation
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Supporting CRO’s in Europe

European regulatory systems are complex and highly demanding.  For CRO’s, especially those outside Europe, navigating the many country-specific requirements is a significant challenge. Developers often find themselves lacking adequate legal representation, failing to appreciate the specific regulatory requirements (even when FDA approval has been gained), and struggle to understand how best to approach the market to maximise access.

With offices in the UK and in mainland Europe, IDEA can help you unlock the EU market by providing legal representation, regulatory planning and submission, and market access strategy services.

We provide:

  • Respected and experienced EU Legal Representation
  • European regulatory and market access strategy
  • European regulatory submissions

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