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Local Support in the UK – BREXIT

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Asphalion offers regulatory solutions in the United Kingdom

Entities and organisations:
– Act as your UK-based MAH
– Act as your UK-local contact with MHRA
– Re-establish your SME status
– Responsible Person for Import (RP-I)

Pharmacovigilance:
– Act as your UK-QPPV
– Reporting adverse events and submissions of PSURs to MHRA
– Batch update all your records with the new QPPV and PSMF information in the Article 57 database
– Hold your pharmacovigilance system master file at our location

Pre-approval:
– National Scientific Advice with MHRA
– UK Orphan Drug Designation Application
– UK PIP
– Clinical Trial Application

Registration and post-approval:
– Submission in UK using the new National Portal
– National procedures in UK; accelerated and rolling reviews, national variations
– Amended packaging and leaflet
– Baselines for grandfathered centralized products

We can also:
– Asses your regulatory impact and develop your Brexit transition strategy
– Manage MAH transfers and other necessary variations

 

How to contact our office in the UK?

Mail: london@asphalion.com
Address: Wells House 80, Upper Street, London, N1 ONU, United Kingdom
More information

 

Brexit

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




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    • 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

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

    Madrid Office
    madrid@asphalion.com
    +34 910 483 817

    London Office

    london@asphalion.com

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