We give distributors and marketing authorisation holders a complete, locally-compliant pharmacovigilance capability without the overhead of building one in-house.
Local PV System Setup
Establish and maintain a robust local pharmacovigilance system tailored to distributor operations and regulatory requirements.
Adverse Event Reporting
Efficient collection, assessment and reporting of adverse events from distributed products, ensuring timely compliance with local and global regulations.
Literature Surveillance
Ongoing monitoring of local and international literature for safety signals and regulatory intelligence relevant to distributed products.
Regulatory Liaison
Direct support for communication with health authorities, including preparation for audits, inspections and regulatory queries.
Compliance Documentation
Preparation and maintenance of all required PV documentation, including SOPs, agreements and compliance records for distributors.
Signal Detection & Risk Management
Proactive identification and management of safety signals, with tailored risk minimisation strategies for distributed products.
24/7 PV Support
Round-the-clock support for urgent PV issues, adverse event intake and distributor queries.
Global & Local Compliance
Expert guidance to ensure distributor PV systems meet all local and international regulatory requirements, including EMA, MHRA and FDA.
