Discover Our Tailored PV Expertise
From drug safety to regulatory guidance, Zenith PV offers boutique services designed for Canadian pharma innovators—ensuring seamless alignment with Health Canada, FDA, and EMA standards.
Our SERVICES
Comprehensive Pharmacovigilance Solutions for Your Compliance Needs
We specialize in customized pharmacovigilance and compliance solutions that adapt to your unique operations. Whether you're a mid-sized developer of biologics, devices, or prescription drugs, our nimble team listens first to craft strategies that exceed expectations and foster product confidence.
From drug safety to regulatory guidance, Zenith PV offers boutique services designed for Canadian pharma innovators ensuring seamless alignment with Health Canada, FDA, and EMA standards.
Our Core Services
Zenith PV provides a full suite of services to support your pharmacovigilance journey. Each service is backed by our expert network and commitment to transparency, speed, and client satisfaction. Dive into the details below or visit dedicated pages for in-depth insights.
Pharmacovigilance (PV)
Drug Safety Monitoring for GVP Compliance
Integrated monitoring and reporting for pharmaceuticals, biologics, and devices, including bilingual ICSR processing, literature screening, and AI-enabled tools to ensure Health Canada GVP adherence.
Key Features :
- End-to-end case processing with MedDRA coding and narrative writing.
- Periodic CVD screening for complete AE capture.
- Validated safety database for KPI tracking.
Medical Information (MI)
Compliant Inquiry Handling for HCPs and Patients
Expert management of medical inquiries, providing accurate, bilingual responses and AE reporting to support product information needs while maintaining regulatory compliance.
Key Features:
- Bilingual call center for efficient query resolution.
- Onboarding trainings for team readiness.
- Integration with safety databases for seamless data flow.
Regulatory Affairs (RA)
Guidance for Submissions and Global Compliance
Strategic support for NDS/sNDS submissions, approvals, and ongoing regulatory intelligence, covering niche areas like oncology, rare diseases, and medical devices.
Key Features:
- eCTD publishing for electronic submissions.
- AI-driven monitoring of FDA/EMA/Health Canada updates.
- Custom strategies for generics and gene therapies.
Quality Assurance (QA)
Systems for Audits and Continuous Improvement
Robust QA frameworks including audits, QMS development, and self-inspections to maintain high standards in PV processes and achieve compliant ratings.
Key Features:
- Remote/on-site audits with gap remediation.
- Training refreshers for GVP compliance.
- Downloadable guides for audit success.
Hospital ADR Reporting (Vanessa’s Law)
Mandatory Adverse Reaction Support for Hospitals
Specialized assistance for Vanessa’s Law requirements, ensuring timely ADR reporting, database screening, and compliance for hospital settings.
Key Features:
- Periodic AE capture and notifications.
- Bilingual expert oversight for accuracy.
- Integration with existing PV systems.
Why Choose Zenith PV for Your Services?
Unlike generic providers, Zenith PV starts with a free gap analysis survey to understand your needs, then delivers boutique solutions with direct senior partner access. Our focus on trust, reliability, and speed means faster compliance, reduced risks, and enhanced brand preference backed by our bilingual Canadian experts.
