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AmoSey Inc.

Mississauga, ON · Canada

Pharmacovigilance & Drug Safetysmall

Specialization: Pharmacovigilance, regulatory and quality consulting

Key Differentiator

Combines pharmacovigilance with Health Canada regulatory and quality work in one small firm.

Core Services

PSMF development; SAE and AE reporting; Literature monitoring; Signal detection; PSURs; GVP compliance and PV audits; DIN, NPN, MDL and DEL applications

Capabilities

Pharmacovigilance system master file (PSMF) developmentAdverse event and SAE reportingLiterature monitoring and signal detectionPSURs and risk management plansGMP, ISO 13485 and MDSAP auditseCTD and non eCTD publishing (REP, CESG)

Market Intelligence

Consultancy in the Greater Toronto Area with an office at 7215 Goreway Drive, Mississauga. Serves drug, biologic, natural health product, medical device and food companies.

Website

www.amoseyinc.com

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