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SafetyEasy™ - Pharmacovigilance and Multivigilance Management Software

The most cost-effective drug safety database software for effortless E2B(R3) pharmacovigilance compliance, but also for medical device vigilance, cosmetovigilance and nutrivigilance.

Understanding the risks and benefits associated with pharmaceutical products, medical devices, cosmetics and food & dietary supplements, brings with it the need for more efficient and effective safety solutions.

SafetyEasy™ is designed to streamline your pharmacovigilance, medical device vigilance, cosmetovigilance and nutrivigilance processes quickly and effectively. Maintaining safety data is a mandatory regulatory requirement. Yet despite the undoubted benefits it brings, it can be a time-intensive and costly process that ultimately contributes little to bottom-line revenue. 

SafetyEasy™ enables you to minimize costs, and deliver best-practice monitoring and reporting workflows crucial to your business success. Create, review, submit and maintain pharmacovigilance, medical device vigilance, cosmetovigilance and nutrivigilance data and event reports within a single, easy-to-use multivigilance application.


Ensure compliance while increasing efficiency and reducing costs.

Readily monitor safety activities and track submission deadlines.

Assure data reliability and quality via business, technical and internal validation.

An easy-to-use, cloud-based platform requiring minimal training or customization.

Ensuring compliance with E2B(R3) and HL7 eMDR safety regulations

Built specifically to support the E2B(R3) EudraVigilance system and MedDRA coding standards, SafetyEasy™ handles the reporting and management of all serious and non-serious adverse events. Its future-proof approach is able to generate PSUR, PBRER, and DSUR documentation and is ready for forth-coming standards such as IDMP. It also supports eMDR XML file creation. Through an EMA certified gateway, SafetyEasy™ provides you with a direct link to the regulatory authorities, eliminating the need for manual submission of reports.

Streamline workflows, optimize your productivity

SafetyEasy™ also enables you to readily track and monitor the status of workflows with every project in your organisation. Through email notifications and online dashboards, SafetyEasy™ provides users with reminders about imminent activities they need to perform. Now, you can ensure that your team members are staying productive and in the know. This guarantees submission deadlines are met, and other legal obligations are never overlooked again.

Cloud-based pharmacovigilance, medical device vigilance, cosmetovigilance and nutrivigilance software-as-a-service

As a secure, cloud-based service, SafetyEasy™ is lightning quick to implement and requires no customization. In many instances, SafetyEasy™ can be configured and validated within two weeks. Its simple, intuitive, and user-friendly interface speeds user adoption and eliminates the need for extensive training. It is a complete, out-of-the-box solution for health science organisations of any size, location and speciality.

Used worldwide for guaranteed compliance

Used by more than 300 organizations across 90 countries, SafetyEasy™ is the simplest and most cost-effective way to ensure effortless compliance with current and future drug safety regulations. With ICH, EMA, FDA, EU GMP Annex 11, US FDA 21 CFR part 11, and EMA’s Good Pharmacovigilance Practice (GVP) guidelines, SafetyEasy™ is compliant with many regulations and directives from around the world.

Triage and assessment of ICSRs in E2B(R3) with iTAP

iTAP is a fast, efficient solution created to help you with the triage and assessment of your ICSRs in the E2B(R3) format with customizable filters. L2A and/or MLM cases are retrieved from the Eudravigilance database and assessed enabling you to select relevant cases for your product portfolio. Every decision for each ICSR you make is tracked by iTAP so you can upload relevant E2B xml files with SafetyEasy™ directly to your database quickly and easily.



Pharmacovigilance Services

EXTEDO also offers Pharmacovigilance Business Process consulting services, which are tailored specifically to your needs. Based on many years of experience working with drug safety rules and regulations, EXTEDO´s team will help you to identify gaps in your pharmacovigilance processes and help you to develop and implement appropriate strategies PSMF to resolve them.

Click here for more details