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We provide comprehensive and global vigilance services for both drugs and medical devices, from initial clinical development to post-marketing surveillance
Vigilance
KEY FIGURES
60%
Projects related to rare disease and gene therapy
10+
Therapeutic areas
>98%
Case quality score for 2023/2024
SOLUTIONS
Case Management
Safety Regulatory
Signal Detectation & Risk Management
Safety Writing
Post-marketing & QPPV
- Safety database set-up and maintenance
- Case processing from intake through regulatory submission
- Case exchange with partners/affiliates
- Regulatory intelligence
- Reporting of ICSR and Aggregate report to regulatory authorities
- Communication with Health Authorities
- Health Authority electronic systems/portals management
- Develop Risk Management Plan (RMP)
- Identification, investigation, and validation of potential safety signals in accordance with FDA guidance, EMA GVP Module IX, and CIOMS VIII
- Author Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs)
- Author Risk Management Plans (RMP)
- Pharmacovigilance System Master File (PSMF) preparation
- QPPV and LPPV appointment
- Eudravigilance registration
Why partner with VCLS?
Global in-house vigilance resources with extensive experience
With the ability to work around the clock with a global vigilance team, highly qualified safety experts, and agile and dedicated project management, we ensure comprehensive and efficient pharmacovigilance operations.
Integrating Regulatory Compliance into Patient-Centric Vigilance
Successful vigilance of a HealthTech product is based on patient safety. Our Quality and Vigilance systems enable the patient to remain at the centre of all outcomes while complying with stringent global regulations.
Partnering with a company like VCLS who combines regulatory expertise with cutting-edge technology has been a game-changer for our clinical development program. The system’s real-time, actionable insights and comprehensive safety oversight have significantly enhanced our decision-making and risk management processes.
Biotech in France
Head of Clinical
FAQs
How are vigilance responsibilities managed in the US?
Like in the EU, in pre- and post-market vigilance in the US, it is the sponsor (and Marketing Authorization Holder – MAH) who takes ultimate responsibility for vigilance processes and outcomes.
However, unlike the EU, there is no requirement for a qualified person for pharmacovigilance, nor any local representatives.
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Do I have to have a Global Safety Database for a product?
There is no obligation to have one single global safety database, however it is highly recommended.
If you have multiple studies/marketing authorizations in multiple countries, to enable easy aggregated analysis of all safety data for one product.
read more
Related Glossary
Pharmacovigilance
Pharmacovigilance System Master File (PSMF)
Signal
Signal Detection
Safety concern
Questions? Get the answers by our expert team
No two product developments are the same, talk to our experts about your development challenges and we will provide your actional recommendations.