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Pharmacovigilance

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Safety first

We provide Pharmacovigilance and Drug Safety services tailored to our clients’ needs and requirements.

  • Audit PV System and support for set up of Quality System
  • EU-QPPV and local contact services
  • Preparation of PSMF, RMP, PSURs, and handling of Case Management
  • Implementation of Adverse Event reporting tool (PcVmanager)

We have prepared more than 100 Periodic Safety Update Reports (PSURs) for Big Pharma, multinational companies. Thanks to our reliable coordination with local agents, we provide PV local services for more than 30 companies.

PSMF preparation and maintenance for +20 companies.

Pharmacovigilance

 

Social Media Screening 

Do you have the control of the safety information of your drugs on the network?

We can help you to monitor drug safety information that appears on social media sites with a new automatic Active Listening system.

This new system screens throughout the internet (websites, blogs, social media…) to detect adverse drug reactions. Current pharmacovigilance legislation obliges marketing authorization holders to notify adverse drug reactions that appear on their social media sites.

This innovative system allows you, with the same investment of time, to review social media sites as well as the entire internet to detect all adverse drug reactions associated with your products/brands.

Digital Monitoring:

  • Active Listening for Brand/Product.
  • Multiple digital platforms with more than 2 billion URLs.
  • 24/7/365 Monitoring solution.
  • Segment by language and/or country

Results segment by: digital platforms, country, language, product.

Analysis and validation of contents:

  • Expert team.
  • In accordance with legislation and/or client requirements.
  • Immediate communication of detecting adverse drug reactions.
  • Periodic reports.

We can help you to take control of the safety information of your drugs on the network!

Contact us and we will be happy to help you!

social media screening

Do you need support or more information about the services? Contact us!



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  • Regulatory and Scientific Strategy during Development
  • Medical and Scientific Writing
  • Global Submissions
  • eSubmissions
  • ISO IDMP & RIM
  • Life-Cycle Outsourcing
  • Pharmacovigilance
  • CMC solutions
  • Medical Devices
  • ATMPs & Biologics

ASPHALION S.L.

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+34 93 238 5945

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+49 (0)89 039 280

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