Maximizing safety. Minimizing risk.
Good Pharmacovigilance Practice (GVP) is the foundation of patient safety and public confidence in medicines. Whether you are delivering pharmaceuticals, medical devices or natural health products to patients, we offer complete solutions that maximize patient safety and minimize manufacturers’ risks.
Demonstrating product safety and quality monitoring
Our integrated, comprehensive and cost-effective Pharmacovigilance and Medical Information services help ensure compliance with continually evolving regulatory requirements. Our multilingual team of Pharmacovigilance and Medical Information professionals is experienced in Canadian, FDA, and EU pharmacovigilance regulations and reporting standards. This ensures the highest quality of safety data collection and processing to facilitate regulatory compliance across global markets.
Customized reporting of safety information
Our multi-disciplinary team of drug safety specialists provides a range of critical solutions that can be customized to meet your requirements, including support for:
Reporting of Individual Case Safety Reports (ICSRs) related to Adverse Events (AEs)/Safety Information
Product Quality Complaints (PQCs)
Source Data Quality Checks
Standardized compliance monitoring process
Validated databases with E2B connectivity and gateway submissions
Our responsibility to your business
Our drug safety specialists are trained to ensure compliance with Pharmacovigilance requirements at the intake level, through source data verification and the monitoring of Key Performance Indicators (KPIs). Our expert team stays ahead of your Pharmacovigilance requirements by maintaining the documentation and tools you need, including:
Medical Information support
Working alongside you, our Medical Information (MI) specialists develop programs customized to meet your service needs. Beginning with intake, triage, assessment, and submission of medical/product information, we further support you by generating standardized responses, letters and FAQ sheets for efficient management of MI requests. Our MI specialists provide support in both English and French, with translation services for 180 additional languages, if needed.