Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions
By Monika Jain, PhD -
Published 02 June 2017
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.
Categories: Features, Japan, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, PMDA, TGA, Drugs, Submission and registration
Tags: Quality Certificates, eCTD, GMP