ZENITH PV

ZENITH PV

Pharmaceutical Manufacturing

Comprehensive Pharmacovigilance and Medical Information Solutions #patientsafety #pharmacovigilance #medinfo

About us

Woman-Owned, Bilingual Canada-based firm specializing in all Pharmacovigilance aspects in post-market setting, including but not limited to: PV self-inspection and GVP audit readiness support, systems and SOP set-up, bilingual ICSR processing, medical assessment, MedDRA coding, CIOMS narrative writing, expedited reporting, aggregate reports compilation (ASRs, PSURs ..etc.), and Medical Information Support for pharmaceutical drugs and advanced biological treatments. Founded on the principles of: Trust, Ownership, Reliability and Speed. Whether you are launching new treatments in Canada, expanding your operations, or simply looking to augment your PV/Medical team through temporary staffing, we will work with you to develop an appropriate solution. Our comprehensive PV and Med Info solutions can be customized to meet your internal company needs as well as Health Authority requirements. Our technical capabilities, solutions-oriented mindset, and ability to leverage industry networks help get the job done. Trust us to deliver a high quality and efficient service that meets all Canadian and key global regulatory agencies. Contact us today: info@zenithpv.ca or at +1 (416)-807-5441

Website
https://zenithpv.ca/
Industry
Pharmaceutical Manufacturing
Company size
2-10 employees
Headquarters
Toronto
Type
Privately Held
Founded
2020
Specialties
Drug Safety, Pharmacovigilance, Medical Information, Medical Writing, Aggregate reports compilation, ICSR Processing, MedDRA coding, Health Canada GVP Audit Readiness Support , and PV Self-inspection Support

Locations

Employees at ZENITH PV

Updates

  • 🎉 Au nom de l'équipe de ZENITH PV; nous vous souhaitons des joyeuses fêtes à vous et à vos proches! Ce fut un grand plaisir de travailler avec nous clients au cours de la dernière année, et nous rejoissons de continuer notre collaboration dans les années à venir 🎉 On behalf of the ZENITH PV team, we wish you and your loved ones a Happy Holiday Season! It has been a great pleasure working with our clients over the past year, and we look forward to continuing our collaboration in the years to come #happyholidays #newyear #collaboration #success

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  • ‼️ Want to learn more about medical device incident (MDI) and adverse drug reaction (ADR) reporting requirements by Canadian hospitals? 📆 Join an insightful discussion presented by our Founder Manar Hammood on January 14th, 2025, in collaboration with the Canadian Society of Healthcare-Systems Pharmacy - Ontario Branch 📌 For registration details or to learn more about the reporting requirements contact us at info@zenithpv.ca #medicaldevice #pharmacueticaldrugs #MDI #ADR

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  • AI Meets Regulatory Sciences 💡 Artificial Intelligence is transforming drug safety and regulatory practices. Health Canada is leading the way with global collaborations and new tools like the Algorithmic Impact Assessment. In our latest blog, we cover: 1. Key updates on AI in pharmacovigilance 2. Actionable insights for aligning with evolving standards 3. How Zenith PV can help you integrate AI responsibly ➡️ Stay ahead of the curve and future-proof your compliance processes. Read more here: https://lnkd.in/gy7_Cks4 #ArtificialIntelligence #Pharmacovigilance #DrugSafety #RegulatoryCompliance #ZenithPV

    Harnessing AI to Improve Drug Safety and Regulation: Zenith PV’s Expert Insights

    Harnessing AI to Improve Drug Safety and Regulation: Zenith PV’s Expert Insights

    ZENITH PV on LinkedIn

  • Health Canada's RMP Modernization: What It Means for You The regulatory landscape is evolving! Health Canada’s modernization of Risk Management Plans (RMPs) aims to enhance predictability, transparency, and lifecycle safety management. Are you prepared to align your submission practices with these updates?   At Zenith PV, we’re here to help. Our latest blog unpacks: 1. Key updates to RMP review processes 2. Practical recommendations for compliance 3. How Zenith PV supports your regulatory strategy Stay ahead of the curve and navigate these changes with confidence. Read the full blog here: https://lnkd.in/gVeq8FJa   #RegulatoryCompliance #Pharmacovigilance #RMPModernization #HealthCanada #ZenithPV #DrugSafety #LifeSciences

    Navigating Health Canada's RMP Modernization: Zenith PV’s Expert Insights

    Navigating Health Canada's RMP Modernization: Zenith PV’s Expert Insights

    ZENITH PV on LinkedIn

  • Thank you for making the Zenith PV Foreign Actions Monitoring Webinar Engaging! We were thrilled to have such an engaged audience join us for a deep dive into #HealthCanada’s new Foreign Actions Notification requirements. The insightful discussions and your thoughtful questions highlighted one key theme: Time is of the essence. With the January 6, 2025, compliance deadline fast approaching, it’s critical to ensure your processes are aligned with Health Canada expectations.  Whether it’s setting up automated monitoring, streamlining your CESG submissions, or training your teams, ZENITH PV is here to help. Don’t Delay – Book Your Free 1-Hour Consultation Today! Let’s work together to: 1. Assess your current Foreign Actions Monitoring readiness 2. Identify compliance gaps 3. Develop a tailored plan to ensure you meet the January 6th deadline Spaces are limited, and the holidays are right around the corner. Secure your consultation slot now to ensure your team is set up for success before year-end! Schedule your session here: https://lnkd.in/gykTPjKm Prefer email? Contact us at info@zenithpv.ca We look forward to partnering with you! #ForeignActionsCompliance #HealthCanada #Pharmacovigilance #ComplianceExperts #ZenithPV #RegulatoryExcellence

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  • DIA Canada 2024: Driving Innovation, Compliance, and Collaboration This year’s DIA Canada Annual Meeting was a dynamic gathering of professionals committed to driving innovation, compliance, and collaboration in the healthcare industry. Over two action-packed days, thought leaders and industry experts came together to exchange insights, explore challenges, and shape the future of healthcare in Canada. One of the standout moments? The session "Pharmacovigilance Unleashed: Unlocking PV Best Practices Through KPIs and Data Mining", where our very own Manar Hammood, Founder of Zenith PV, delivered a compelling case on how KPIs can revolutionize pharmacovigilance operations. Her expertise sparked vibrant discussions on how data-driven insights can elevate compliance and patient safety. (Check out the session details here: https://lnkd.in/dAaRKecq). At ZENITH PV, we’re committed to keeping the conversation alive! Over the next four weeks, we’ll be sharing key highlights and insights from this inspiring event. From pharmacovigilance breakthroughs to strategies for medical information excellence, you won’t want to miss it. Follow us to stay updated and be part of this exciting journey toward safer, more effective healthcare solutions. Let’s keep building a future where data and innovation work hand-in-hand for better patient outcomes. #DIA2024 #Canada24 #Pharmacovigilance #KPIs #HealthcareInnovation #ZenithPV

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  • Exciting Day 1 at the DIA Canada Annual Meeting! We’re thrilled to kick off Day 1 of the #DIACanada Annual Meeting in Toronto! Join us at our booth to connect, collaborate, and learn more about how Zenith PV is advancing regulatory compliance for Canada’s pharmaceutical and biotech industries. With new Health Canada requirements for Foreign Actions Reporting impacting many companies, this is the perfect opportunity to dive into compliance strategies with our Founder, Manar Hammood. Manar brings years of specialized expertise in drug safety and regulatory affairs and is here to help you navigate these recent changes with confidence. 💬 Stop by our booth today to: - Discover practical steps for seamless Foreign Actions Reporting compliance - Learn how to reduce regulatory risk while protecting patient safety - Explore how Zenith PV’s innovative solutions can support your team 🗓️ Don’t miss today’s sessions on pharmacovigilance, global PV collaboration, and compliance trends that align perfectly with Zenith PV’s mission to support proactive regulatory practices. Let’s work together to elevate compliance standards and foster safer healthcare outcomes across Canada! #DIACanada #DrugSafety #Pharmacovigilance #ForeignActionsReporting #HealthCanadaCompliance #ZenithPV #ComplianceExperts

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  • View organization page for ZENITH PV, graphic

    1,433 followers

    New Health Canada Foreign Actions Reporting Requirements Got You Scrambling? Starting Oct 28, PV teams in Canada must report foreign actions via FDA gateway following REP – and many are struggling to keep up with the sudden changes.   💡 Join us at our DIA Canada booth on Nov 14-15 to see how ZENITH PV can make Foreign Actions Reporting automatic and easy. Our solution enables real-time alerts from global regulatory agencies, transforming foreign action reporting into a seamless, hands-free process. Stop by Zenith PV booth for: 🔹10-Min Rapid Consult to answer your compliance questions 🔹 Interact with our Founder, Manar Hammood or our team and see how you can be ready for this change Contact us to secure a time slot at info@zenithpv.ca #DIACanada #pharmacovigilance #HealthCanada #CESG #RegulatoryCompliance #ZenithPV

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  • In light of the recent Health Canada announcement for Foreign Actions Reporting process update effective Oct 28th, 2024, Zenith PV is hosting this Webinar to walk Canadian MAHs through the scope of change and required adjustment to implement the new reporting process. Registration link is provided below.

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  • Day 2 of World Drug Safety Congress Americas in Boston, US continues to be enriched with insights from different regulatory agencies including Health Canada, FDA and EU regulators. The final key note- One world, one standard: The future of pharmacovigilance is being discussed live by this panel. The availabilty of patient safety data from payor databases to regulators has major implications for PV professionals. #healthcanada #drugsafety #patientsafety

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