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Pharmacovigilance and Medical Devices Vigilance

Leave you Vigilance activities in safe hands with Asphalion

Pharmacovigilance and Medical Devices Vigilance

Asphalion’s expert team provides strategic and operational support for partial or full outsourcing of pharmacovigilance (PV) responsibilities.

With more than 15 years providing PV services, our expertise ensures optimal compliance with national and international PV regulations. Following our commitment to quality, our PV activities are certified according to ISO 9001:2015.

Our flexible PV solutions activities meet the needs from early development to post-commercialization of medicinal products.

Pharmacovigilance and Medical Devices Vigilance Solutions

Human & Veterinary Pharmacovigilance

  • EU-QPPV and Deputy
  • Local PV support covering all EU and ROW countries
  • Global & Local Scientific Literature searches
  • PSMF and PV agreements
  • Aggregate Safety Reports: RMP, DSUR, PSUR/PBRER and ACO
  • Management of ICSRs
  • Drug Safety for Clinical Trials
  • Quality system, SOPs and Audits
  • Medical advisor support and medical information management
  • EudraVigilance support and xEVMPD
  • PV Training
  • Case management using Asphalion’s validated Safety Database
  • Signal management
  • Regulatory intelligence
  • Management of medical information

 

Post-marketing Surveillance (PMS) for Medical Devices

  • Gap analysis/audit of PMS System
  • PMS SOPs definition and PMS plan
  • PMS system set-up
  • Scientific Literature search
  • Safety alerts screening from Competent Authorities websites
  • Incidents & complaints management
  • Field safety corrective actions management
  • Annual PMS report & PSURs & SSCP & PMSR
  • Trend analysis
  • Surveys
  • PMCF analysis and report

Digital Solutions

AsphaSearch

AsphaSearch
Asphalion’s AI-powered tool for global literature searches: Explore Globally, Read Less, Discover More!

Save time and minimize errors with Asphalion’s literature monitoring platform and consolidate your global and local literature searches in a central hub. Simplify and enhance the categorization and analysis of safety data for a more efficient process!

AsphaSearch

AsphaAlerts
Asphalion’s digital tool for Regulatory intelligence: Your Signal to Stay Sharp and Alert!

Identify all Safety & Regulatory alerts from regulatory agencies’ websites, automating Regulatory Intelligence activities for medicinal products & Medical Devices.

AsphaSearch

AsphaDigiMedia
Unlocking Active Listening: Asphalion’s AI-Powered Social Media Screening!

Marketing Authorization Holders are encouraged to conduct routine screenings of the internet and digital media platforms under their management or responsibility, actively seeking potential reports of suspected adverse reactions. Join us for an automated monitoring of safety data mentions across social media platforms!

Schedule a free meeting!

Discuss your case with our experts and receive a valuable feedback

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Why Asphalion?

Asphalion has been named top PV provider in Europe by Pharma Tech Outlook, thanks to its long track record in projects: Asphalion currently provides PV support to more than 90 companies and Asphalion’s own PV system is subcontracted by more than 10 companies.

In addition, Asphalion maintains the PSMF of more than 15 companies and provides local PV services in Spain to more than 30 European and non-European companies.

Main benefits

  • Rely on experts to manage your PV responsibilities efficiently
  • Mitigate your risks
  • Optimize the cost and resources required for your PV program
  • Count on Asphalion to deliver continuous improvement of your PV system
  • Obtain better control and increased efficiency of PV activities
  • Achieve high quality standards for your safety monitoring
Sonia Lopez - Asphalion
Sonia López
Pharmacovigilance Director
“Asphalion is a “one-stop shop”, what enables our clients to interact with a single service provider for all PV and Regulatory requirements, which leads to time, cost and quality optimization”

Related Resources

AsphaNet Video

A network of qualified partners that allows us to provide local pharmacovigilance services across Europe

AsphaAlerts

Introducing AsphaAlerts, your signal to stay sharp and alert!

EU Pharmacovigilance local contact services

EU Pharmacovigilance local contact services

EU Pharmacovigilance local contact services case study. Small biopharmaceutical company with one
pharmaceutical product authorized through
a Decentralized Procedure in 10 European
countries.
The Client has all PV local activities
outsourced to different vendors in each
country, which poses several challenges.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

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