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.

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.

Our 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

 

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

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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”

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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