Month: May 2018

APT, Software Release

ACUTA PDF Tools (APT) version 4.1 released

ACUTA PDF Tools has been updated to version 4.1. It has been enhanced to include the following key features (as well as a few others). TOC Generator Wizard – this is a new tool, that can create TOC pages from the bookmarks (or manual entries) of an existing PDF file PageStamp Wizard – this is a …

ACUTA, ARIM, Conferences, eCTD

ACUTA RIM Shots May 18, 2018

Every once in a while there will be only short subjects to report on Regulatory Information Management-related topics, so welcome to the first ACUTA RIM Shots, where we’ll report on quick news items. ACUTA to Present at Pharmaceutical Regulatory Affairs June 8 Joel Finkle, Director of Regulatory Innovation and IDMP Strategy, will have two presentations …

ACUTA, ARIM, Australia, eCTD, Validator

ACUTA Validator now listed by the Australian agency

In November of 2017, we reported the details of Australia’s updated guidance for version 3.1 of their regional eCTD specifications. ARIM Suite Version 3.2, which was released shortly after that, provided full support for publishing and validating Australian submissions. While ACUTA Validator has been capable of accurately validating submissions to Australia’s Therapeutic Goods Administration (TGA) …