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Pharmaceutical Drug Product Registration and Requirements in Latin American CountriesBy Bengre P., Dixit M., Charyulu R.N., Shetty A., Rao M.S., Thomas S.
Abstract: The regulatory process to obtain marketing authorization’s (MAs) for drugs in Latin American (LATAM) countries, despite regional harmonization efforts, is highly country-specific. This article offers a practical overview of product registration processes in LATAM. Although the International Conference on Harmonization (ICH) Common Technical Document (CTD) can serve as a resource for most local MA applications, it is not necessarily required in its full length. Additionally, a significant amount of mandatory …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 1, Issue 3, 2014 · pp. 22–29 Read article →