Pharmacovigilance and Drug Safety Services

At Asphalion, we provide Pharmacovigilance and Drug Safety services tailored to our clients’ needs and requirements.

Our services are framed within the most updated and best pharmacovigilance practice, such as the European Medicines Agency (EMA) pharmacovigilance guidelines.

The importance of pharmacovigilance

Pharmacovigilance plays a fundamental role in patient care worldwide, as it facilitates the monitoring of drug safety, from the initial evaluations to the mass consumption stage.

Our Pharmacovigilance Consulting Services

• 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)

Why choose Asphalion as your Pharmacovigilance Consultants

We have prepared more than 100 Periodic Safety Update Reports (PSURs) for Big Pharma, multinational companies. Our company stays up to date in regards of pharmacovigilance requirements and regulations.

Thanks to our reliable coordination with local agents, we provide PV local services for more than 30 companies, as well as PSMF preparation and maintenance for +20 companies.

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 drug safety 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 regarding your Pharmacovigilance needs and we will be happy to help you!