AmoSey Inc.

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Expert Services. Proven Results.

Our services

Delivering Quality Solutions Designed for Your Success.

Core service areas

Regulatory Affairs

DIN · NPN · MDALL · DEL applications · new drug or generic submissions · Health Canada liaison · product lifecycle management · labelling submissions · advertising compliance · ITC

Quality & Compliance

GMP audits · ISO 13485 · MDSAP · QMS development · SOP writing · CAPA management · inspection readiness · validation programs

Pharmacovigilance

PSMF development · SAE & AE reporting · Literature Monitoring · Signal detection · PSURs · GVP compliance · Risk management plans · PV audits.

eCTD/Publishing

REP · CESG · eCTD · non eCTD · PM XML

Expertise You Can Trust

15+ years of hands-on regulatory experience

Global Regulatory Reach

Serving clients across North America, Europe, Asia & more

Up-to-Date Industry Insight

Always aligned with current regulations & standards

Reliable, End-to-End Support

Responsive, detail-focused guidance at every stage

Have a query? Let us know!

647-624-9628

jai@amoseyinc.com