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Global Submissions

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Providing the vision and experience to manage global submissions

We provide reliable support for all types of regulatory procedures and all types of dossiers. We coordinate your submissions, liaise with agencies, and resolve all potential hurdles.

Many of our regulatory experts have decades of experience in these activities, making Asphalion your partner of choice. We have experience in all European countries, in the US, in Canada, LATAM countries and increasing coverage of RoW countries.

  • Assessment of regional requirements
  • Support and Management of new marketing authorization submissions to comply with critical timelines
  • Centralized Procedures (CP) in EMA
  • Decentralised Procedures (DCP) with all European Agencies and National Phases (NP)
  • FDA projects (IND, NDA, BLA, ANDA)
  • Global roll-out in emerging markets
  • Reliable coordination of local partners for global registration procedures (RoW)

With 20 years’ track record in handling submissions, we have gained experience in the compilation of almost all types of submission dossiers: New Chemical Entities, Biologicals and Advanced Therapy Medicinal Products, Orphan Drugs, Generics, OTCs, Herbal Medicines, Homeopathic Medicinal Products, Veterinary Medicinal Products, Medical Devices, Cosmetics and Food Supplements.

Translation Management

We have extensive experience with the management of translations.
Especially for Centralised Procedures, in which time and accuracy is critical, we can support you to manage all required activities.

In EU Centralised Procedures we manage translations from pre-opinion, until linguistic review and opinion by agencies.
Also for maintenance activities, we can organize to manage the translations in all EU languages. We can check the national translations internally, with the customer / affiliates and/or our dedicated translation service provider.

We update all necessary texts and coordinate the communication with National Agencies and affiliates, if required.

Our preferred translation provider has been audited and approved for use within our ISO validated quality system.

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




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    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.
    • 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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