eCTD Guidelines

Following electronic Common Technical Document (eCTD) guidelines significantly reduces the time and resources required for compiling applications for registration of pharmaceuticals.

The eCTD guidelines are the set of specifications for a dossier for the registrations of medicines. As the common format agreed upon by the governing regulatory bodies in Europe, Japan, and the U.S., the eCTD guidelines serve as the technical requirements for submissions of applications to register pharmaceuticals for human use in those regions. A comprehensive and well-prepared eCTD guideline-adherent regulatory application is essential to smooth approval and registration processes and extremely beneficial in getting products to market sooner.

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