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ASPHALION S.L.

About ASPHALION S.L.

ASPHALION is an international Regulatory, Scientific & Safety consultancy company with offices in Barcelona, Madrid, Munich and London.  Its strong track record has made ASPHALION a reference in the international healthcare sector and a key stakeholder in the implementation of new regulatory standards delivering solutions to Pharmaceutical, Biotechnological and Medical Technology companies by offering strategic advice, expert consulting, operational support, as well as full outsourcing services for all types of products in all therapeutic areas.

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  • ES
  • 2016
    On CPHI since
  • 100 - 249
    Employees
Company types
Contract Service
Primary activities
Regulatory Affairs
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Products from ASPHALION S.L. (7)

  • Esubmission Services

    Product Esubmission Services

    Asphalion S.L offers wide range of services which includes esubmission services. it has been at the forefront of electronic submission of regulatory data since the introduction of ectd. Experience is reflected in the countless valid ectd and nees submissions. It consist of preparation of ectd/nees for: eur...
  • Optimized Product Maintenance Services

    Product Optimized Product Maintenance Services

    Asphalion S.L offers wide range of services which includes optimized product maintenance services. It constitutes a large part of the workload of regulatory departments. Up to 70% of the activities during the life cycle of a medicinal product could involve maintenance. Product maintenance is thus a field w...
  • Regulatory Strategy Services

    Product Regulatory Strategy Services

    Asphalion S.L offers wide range of services which includes regulatory strategy services. Its strategic inputs from the very beginning: segmentation/niche indication, conditional approval/fast track, orphan drug designations, preclinical and clinical plans with minimum time-to-market, and others. Contact us...
  • Regulatory Support During Development Services

    Product Regulatory Support During Development Services

    Asphalion S.L offers wide range of services which includes regulatory support during development services. It is an expertise for optimal outcome with ema, eu-ncas, fda. Scientific advice can be a key issue for optimal development and fast and successful product registration. R&d and regulatory project man...
  • Submission Management Services

    Product Submission Management Services

    Asphalion S.L offers wide range of services which includes submission management services. It provides reliable support for all types of regulatory procedures and all types of dossiers. It coordinate the submission, liaise with agencies, and resolve all potential hurdles. Many of the regulatory experts hav...
  • Training Services

    Product Training Services

    Asphalion S.L offers wide range of services which includes training services. It has high-level training activities with the goal of developing the practical skills of professionals who want to expand their knowledge and abilities and realize their own personal potential. Team of trainers has in-depth know...
  • Writing And Authoring Services

    Product Writing And Authoring Services

    Asphalion S.L offers wide range of services which includes writing and authoring services. It is a preparation of complete and compliant ctd registration dossiers for all types of products: clinical overviews and summaries (modules 2.5/2.7), non-clinical overviews and summaries (modules 2.4/2.6), quality d...