GxP Digital Tools
Zenith PV's suite of digital tools combines AI-driven intelligence with validated systems, tailored to your Canadian pharma needs for efficient safety tracking, submissions, and monitoring.
CONSULTING
Innovative GxP Digital Tools for Seamless PV and Regulatory Operations
Zenith PV's GxP digital tools are designed to support the evolving needs in local and global Healthcare for precision and proactive monitoring of safety data and streamline regulatory submissions. Our secure and validated PV, MI, and RA tools offer compliant and user-friendly interfaces while complying to data privacy standards such as PIPEDA and HIPAA and data protection acts. From tracking KPIs in real-time to automating global regulation scans, these tools integrate seamlessly into your workflows, reduce manual efforts and foster confident decision-making for prescription drugs, medical devices, and advanced therapies.
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Book a discovery call with a Zenith PV senior partner today to discuss your needs, uncover gaps, and kickstart your compliance journey.
Our GxP Digital Tools Overview
Our tools offer nimble integration, bilingual capabilities, and proactive features to address your specific challenges ensuring data integrity, timely submissions, and informed monitoring
Validated Safety Database for Real-Time Tracking
Zenith PV's safety database offers custom access to a fully validated platform for managing pharmacovigilance data, enabling seamless tracking of adverse events, signals, and compliance metrics. With user-friendly dashboards, you can monitor the entire case lifecycle from intake to reporting while viewing key performance indicators (KPIs) like processing times and reporting accuracy. Bilingual interfaces support Canadian requirements, and integration with your existing systems ensures data transparency without disrupting workflows, ideal for mid-sized developers handling DINs, NPNs, or biologics.
Bilingual Call Center for Efficient Inquiry Handling
Our medical information call center provides bilingual solutions in English and French for managing healthcare professional (HCP) and patient inquiries, while capturing adverse event (AE) data for escalation to PV systems. With 24/7 availability options, it ensures quick resolutions to product questions, usage guidance, and safety concerns, integrating seamlessly with safety databases for real-time AE management. This tool supports compliance with Health Canada guidelines, reducing response times and enhancing trust in your products through accurate, non-promotional information.
Streamlined eCTD Publishing for Regulatory Submissions
Zenith PV's eCTD publishing tool facilitates electronic Common Technical Document (eCTD) services for regulatory submissions, ensuring compliant formatting and validation for Health Canada, FDA, and EMA filings. We handle dossier compilation, hyperlinking, and publishing for NDS/sNDS, with features for version control and audit trails to simplify complex submissions in oncology, rare diseases, or gene therapies. This digital solution accelerates review processes, reducing errors and supporting your path to market approval with precision and efficiency.
Regulatory Intelligence
Our automated regulatory intelligence tool is set-up to monitor global regulations and foreign authorities’ sites to comply with Health Canada notification of foreign actions requirement. With built-in machine-translation and validated keyword searches for timely alerts on safety risks, recalls, label updates, and guidelines and policy changes. Zenith can support you with the assessment of the identified alerts to ensures proactive compliance with Health Canada 72-hour NFA notification timelines, in the required format.
Data that drives decisions.
Integration and Benefits of Our Digital Tools
Zenith tools create a unified compliant system to link safety insights and medical queries to signal identification and prioritization. eCTD publishing for foreign actions notifications and label changes while maintaining regulatory intelligence for informed updates. Our approach minimizes silos, enhances data flow, and supports compliance across PV, MI, RA, and QA, all with our boutique touch of customization and direct senior access.
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