Submission Management Services

Submission Management Services
Product Description

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 have decades of experience in these activities. Contact us for more information.

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ASPHALION S.L.

  • ES
  • 2016
    On CPHI since
  • 100 - 249
    Employees
Company types
Contract Service
Primary activities
Regulatory Affairs
View company profile
Categories
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Specifications
  • Selling Points
    Packaging; Quality Service
  • Supplied from
    Spain
More specifications Fewer specifications
Sales Markets
Show more Show less

ASPHALION S.L.

  • ES
  • 2016
    On CPHI since
  • 100 - 249
    Employees
Company types
Contract Service
Primary activities
Regulatory Affairs
View company profile

More Products from ASPHALION S.L. (6)

  • 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...
  • 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...