Major Drugs - Oakville, ON, CA
Certus PV provides pre-approval and post-market pharmacovigilance (PV) expertise for pharmaceutical drugs (brand and generic), biologics, radiopharmaceutical drugs, natural health products, medical devices and cosmetics. Our experienced staff deliver PV services at all levels including specialist, strategic, and safety physician services. The Certus PV team is led by Rita Cassola, a registered pharmacist, and Agnes Jankowicz, a pharmacologist and toxicologist. Rita and Agnes bring over twenty-five years of combined Canadian and global experience in PV and medical information and are recognized as expert PV auditors, trainers and presenters. In addition, Dr. Arshi Kizilbash (Safety Physician) brings to the Certus PV team nearly a decade of clinical practice and over 16 years of extensive experience in patient safety and pharmacovigilance. Our PV professionals can lead or support your pharmacovigilance activities with the required rigor. Our consulting services include: • Pharmacovigilance Self-inspections and Gap Analyses • GVP Inspection Preparation and Assistance • Pharmacovigilance Training Customized to Meet Your Needs • Pharmacovigilance Agreements • Pharmacovigilance Standard Operating Procedures • Safety Physician Services • Foreign Marketing Authorisation Holder and/or Importer GVP Services • Benefit–Risk Assessments • Risk Management Plans • Aggregate Reports • Individual Case Safety Report Processing
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