Pharmaceuticals - Montreal, Quebec, Canada
20+ 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 AreasInnovative drugsGeneric drugsBiologics/biotechnologyActive Pharmaceutical IngredientsSubsequent entry biologicsVeterinary medicineCosmeticsMedical devicesNatural health productsOTC/non-prescription drugsDrug/device combination productsCBD IndustryVeterinaryRadiopharmaceuticalsOtherJurisdictionsCanadaUSEurope (EU)Non-EU EuropeAsiaAustralia / New ZealandLatin AmericaWorldwidePharmakon, 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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