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Regulatory and Scientific Strategy during Development

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Establish the right strategy by relying on experts

The regulatory strategy is the best pathway to draw up suitable development plans.

The experience of Asphalion team allows the selection of best regulatory strategy from all existing possibilities.

Strategic inputs can be given from the very beginning for segmentation/niche indication, conditional approval/fast track, orphan drug designations, preclinical and clinical plans with minimum time-to-market, and others.

Roadmaps: non-clinical and clinical development plans, including assessment of feasibility, strategy, timelines and costs

Scientific Advice: expertise for optimal outcome with EMA, EU-NCAs, FDA and other agencies

  • Paediatric Investigation Plan (PIP)
  • Orphan Drug Designation (ODD)
  • Clinical Trial Application (CTA)
  • Investigational Medicinal Product Dossier (IMPD)
  • Investigator’s Brochure (IB)
  • Regulatory Partner for Horizon 2020 Program

Asphalion has already worked in 15 successful PIPs and 20 ODDs, along with Parallel FDA and EU submission for Fast Track / Conditional Approval. Our experts have participated in Scientific advice with EMA as well as National Competent Authorities such as, PEI, AEMPS, DKMA, CbG, MPA, among others. We have been involved in the UAT of EMA for the new CT portal, and worked with EudraCT  and clinicaltrials.gov.

Besides, Asphalion has already been involved in 10 EU H2020 funded projects: iHIVARNA, MYOCURE, ELASTISLET, iHIVACAR, nTRACK, CardioReGenix, SBR , MISTRAL, VASCOVID and ARDAT.

Do you need support or more information about the services? Contact us!




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    RELATED NEWS AND EVENTS

    Brexit advice: Schedule a meeting with us!

    Recently, we have received a lot of questions regarding Brexit and the changes it might imply for your business. Because of this, we are offering free consulting sessions with one of our Regulatory experts to discuss your projects and needs.

    Sonia López- New Pharmacovigilance Director at Asphalion

    Asphalion’s Board of Directors is pleased to announce the appointment of Sonia López as new Pharmacovigilance Director.

    Marta Rayo Lunar- New Scientific and Regulatory Affairs Director at Asphalion

    Asphalion’s Board of Directors is pleased to announce the appointment of Marta Rayo Lunar as new Scientific and Regulatory Affairs Director.

    BREXIT | Latest updates in Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP

    As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.
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    Javier Febrero Alija – New Regulatory Information Manager

    Asphalion is excited and proud to officially welcome Javier Febrero Alija to its team as Regulatory Information Manager, expert in Data Management and RIMS.
    • Regulatory and Scientific Strategy during Development
    • Medical and Scientific Writing
    • H2020 Programme | Regulatory Partner
    • Global Submissions
    • eSubmissions
    • ISO IDMP & RIM
    • Local Support in Spain
    • Local Support in the UK – BREXIT
    • Life-Cycle Outsourcing
    • Pharmacovigilance
    • CMC solutions
    • Medical Devices
    • ATMPs & Biologics

    ASPHALION S.L.

    HQ – Barcelona
    info@asphalion.com
    +34 93 238 5945

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    munich@asphalion.com
    +49 (0)89 039 280

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