Pharmakon Consultants
25+ years of Regulatory Affairs and Compliance experience. Product development, submission preparation, filing, follow-up/negotiation with authorities, post-approval commitments/maintenance. Baseline assessments, due diligence, gap analyses. Regulatory Affairs training courses. Audit readiness/enforcement. CAPA Management/Effectiveness Monitoring. Pharmacovigilance support. Product Areas Innovative drugs Generic drugs Biologics/biotechnology Active Pharmaceutical Ingredients Subsequent entry biologics Veterinary medicine Cosmetics Medical devices Natural health products OTC/non-prescription drugs Drug/device combination products CBD Industry Veterinary Radiopharmaceuticals Other Jurisdictions Canada US Europe (EU) Non-EU Europe Asia Australia / New Zealand Latin America Worldwide Pharmakon, in Ancient Greek philosophy and critical theory, is a composite of three meanings: remedy, poison, and scapegoat. Contact us and let us help you choose the right meaning.
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