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HomeResource LibraryEffective Pharmacovigilance & Regulatory EU and Australian...

Situation.

Our client is the proprietary owner of a haemophilia drug portfolio, clinical programs which is seeking to change the lives of haemophiliacs, across the World. Client is a US-based, SME Biotech and have engaged with the European Medicines Agency (EMA) and EU national authorities through Scientific Advice. Several EU designations have also been sought and approved. At the time, services from their current EU providers were considered disjointed and ‘operational’.

Approach.

  • Consultative: The BE Consults (BEC) team held two consultative calls with the client, to discuss and understand the current situation of their programmes in Europe. Some products were considered for multiple indications with study protocols under discussion. These consultative calls were based on a non-committal, ad-hoc consultancy service.
  • Expertise: As a next step, BEC agreed to undertake and submit a comprehensive Due-Diligence Report, which enabled the client and BEC to re-evaluate their current strategies in Europe and Australia and focus attention on specific areas such as; PRIME Eligibility, Orphan Designation and EMA and TGA Scientific Advice. Additional support has been recently requested for pre-registration Pharmacovigilance.
  • Proactive: Our regulatory leads have worked closely with the Client’s CMO and regulatory team, providing timely and expansive functional support as and when required. Bionical Emas are proud to be considered an extension of the client’s EU operations.

Outcomes.

  • Reset course for the client’s development programs in Europe
  • Clear strategy which continues to provide a consultative service, on an ad-hoc basis
  • A collaborative approach in which there is a common objective…to recognise the full potential of these products which may offer a significant therapeutic advantage to patients
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BE Consults

The Bionical Emas team is your ideal strategic, regulatory, consultancy partner. Providing a range of services, from ad-hoc, specific regulatory, technical or therapeutic advice, to comprehensive, full-service provisions. We provide a range of drug development solutions for our clients, including; Regulatory Services, Quality Assurance, Data Management, Pharmacovigilance, Clinical Operations and Early Access Programs.

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