Consulting
Founded on our core values of trust, ownership, reliability, and speed, We offer tailored consulting to optimize regulatory (RA, PV & QA) operations, from gap remediation to strategic overhauls, ensuring compliance with Health Canada requirements while fostering innovation in advanced biologics, prescription drugs and medical devices.
CONSULTING
Your PV Potential with Expert Guidance
Our approach stands out in Canada's growing PV landscape, where the pharmacovigilance market is projected to expand at a CAGR of 7.9% from 2025 to 2030, driven by increasing regulatory demands and safety focus. We deliver proactive, transparent solutions that reduce costs and enhance efficiency, as evidenced by global trends showing PV outsourcing and consulting leading to up to 50% reductions in adverse event processing times.
We believe consulting is more than advice it's a collaborative partnership where we listen intensely to your unique challenges and craft bespoke strategies that propel mid-sized pharma developers forward.
Our Consulting Process
We begin every engagement with a free gap analysis survey, then move through collaborative planning, implementation, and ongoing monitoring to ensure measurable results. This nimble process adapts to your scale, whether addressing signal detection for small databases or aligning PV with business goals.
Book A Discovery Call
Book a discovery call with a Zenith PV senior partner today to discuss your needs, uncover gaps, and kickstart your compliance journey.
Core Consulting Services
Explore our specialized consulting areas, each designed for mid-sized pharma facing regulatory evolution. While these highlight key focuses, we integrate them into holistic packages.
Customized Trainings for Compliant Teams
Zenith PV's trainings are designed as interactive, bilingual programs that equip your staff with essential pharmacovigilance knowledge, going beyond basics to address real-world scenarios like ADR reporting or signal detection. We offer onboarding for new hires, periodic refreshers for ongoing compliance, and specialized modules for biologics or Vanessa's Law in hospitals. Delivered virtually or in-person, our sessions emphasize practical application, ensuring your team not only meets GVP standards but also contributes to enhanced product safety and brand preference through confident decision-making.
Expert Opinion: Informed Insights for Critical Decisions
Our Expert Opinion service provides precise, evidence-based consultations from Zenith PV's network of seasoned professionals, addressing queries on risk assessments, regulatory interpretations, or safety signal validations. Ideal for mid-sized innovators, we offer ad-hoc advice or in-depth reviews, such as evaluating benefit-risk profiles for oncology drugs or aligning with EMA standards. With direct access to experts like Manar Hammood, this service ensures proactive solutions that precisely tackle issues, backed by qualitative and quantitative analyses for confident, compliant outcomes.
QMS Development & Management: Robust Systems for Sustained Quality
Zenith PV specializes in developing and managing Quality Management Systems (QMS) that integrate seamlessly with your PV operations, incorporating SOPs, CAPAs, and deviation tracking to meet GVP requirements. We start with a gap analysis to build or enhance your framework, then provide ongoing management with regular reviews and updates. This ensures efficient, audit-ready processes for case processing, reporting, and risk management, all while maintaining transparency and scalability for your biologics or device portfolios.
Why Choose us
Why Partner with Us for Consulting
Choose Zenith for benefits like reduced risks through expert-led QMS, empowered teams via trainings, and strategic edges from opinions all with no hidden costs and direct senior access. Clients see enhanced efficiency, compliance peace of mind, and growth in brand trust. Stats: Consulting can yield 40% faster issue resolution and 20-30% cost savings in PV operations.
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