Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions

Posted 02 June 2017 By Monika Jain, PhD

placeholder+image This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan.

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Categories: Drugs, Submission and registration, Features, US, Canada, Europe, Japan, Oceania, FDA, EMA, Health Canada, PMDA, TGA

Tags: Quality Certificates, eCTD, GMP

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