Our top leading history and experience in the Spanish market positions Asphalion as the best partner to ensure rapid commercial success


The drug development process requires a diversity of strategies addressed towards enhancing a product’s value for the society. Therefore, understanding specific local needs, processes, standards, laws and crucial contacts maximizes future market possibilities in each context.

Furthermore, the Spanish market represents one of the biggest potentialities due to the volume of its health expenditure, which positions it as an interesting and essential strategic region. To this purpose, we can offer a deep understanding based on our experience about the local Spanish regulatory environment, as well as its agents, involved authorities, communications flow and calendars, etc., all of them key to ensure a successful and efficient registration, commercialization, and post-marketing product life.

Spain Solutions

  • Local representative in Spain
  • Preparation of Module 1 for Marketing Authorisation Application in Spain
  • Management of national phases of DCPs and MRPs, including: product information translations, mock-ups review and follow-up of procedure until approval
  • Request of National Codes for Centralised Authorised Products
  • National submissions, including Fast-Track procedure
  • Management of Spanish authorities’ portals and databases, e.g RAEFAR
  • Mandatory activities before product launch
  • Marketing Authorisation transfers
  • Local variations and renewals of National Marketing Authorisations
  • Clinical Trial Applications and substantial amendments in Spain
  • Management of medicines for compassionate use
  • Pharmacovigilance strategy and operations:
    • Local Qualified Person for Pharmacovigilance
    • Writing of Periodic Safety Reports
    • Literature monitoring
    • Pharmacoepidemiology
    • ICSR (Individual Safety Case Report) management, including collection, evaluation, processing, distribution and reporting of cases.
    • Preparation of PSMF (Pharmacovigilance System Master File); RMP (Risk Management Plans), PSURs (periodic Safety Update Reports), and handling of Case Management
    • Implementation of Adverse Event reporting tool
    • Social media deep screening to monitor drug safety information within digital environment:
      • Active listening of brand/product
      • Multiple digital platforms with more than 2 billion URLs
      • 24/7/365 monitoring solution
      • Segment by language and/or country
    • Analysis and validation of contents:
      • Expert drug safety team
      • In accordance with legislation and/or client requirements
      • Immediate communication of detected adverse drug reactions
  • Ensuring complete and constant subjection to compliance based on specific regional regulations:
    • Inspection and Audit system and compliance.
    • Audit PV systems and support for Quality System set-up.
    • CMC compliance and regulatory gap analysis.
    • Review of promotional or training materials post-authorization and of commercial activities.
    • Management of labelling.
  • Data retrieval oriented to price and reimbursement purposes
  • Price and reimbursement strategies for new medicinal products and for generic products in Spain
  • Applications for Price revision and increase
  • Request of license of Pharmaceutical Establishment in Spain:
    • Preparation of the Company Master File and SOPs
    • Submission through the electronic portal Labofar
    • Support in inspections
  • In-house implants
  • Continuous update on changes of local requirements

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Why Asphalion?

Asphalion is the largest regulatory affairs consultancy firm in Spain. This has been achieved in parallel to our experts having developed an excellent personal relationship with the national regulatory entity, the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), as well as with the Ministry of Health and its derivative organ bodies, backed up by more than 20 years of presence. Together with our profound understanding of the local legislation and knowledge of agencies’ preferences and internal processes, Asphalion is your best choice as local regulatory partner in Spain. This is complemented by:

  • Extensive knowledge of national and regional agencies know-how
  • 1st hand knowledge of upcoming changes of local legislation and direct involvement in local projects
  • Native speakers of the Spanish language, which facilitates communication and relationship management

Related Resources

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Scientific & Regulatory Affairs Support during development of ATMPs & Biologics

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