Category: ACUTA

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) …

ACUTA, Conferences, IDMP

Join ACUTA at the eRegulatory Summit in Lisbon, April 24-26

ACUTA is proud to be presenting and exhibiting at Informa’s eRegulatory Summit conference at the SANA Hotel, Lisbon on April 24-26, 2018. Joel Finkle, ACUTA’s Director of Regulatory Innovation and IDMP Strategy will be speaking on the 26th, at 16:20, presenting “The RIM around IDMP – How to fill it up” with examples of data …

ACUTA, ARCS, ARIM, eCTD, EMA, FDA

eCTD – What are you waiting for?

I’ve now been with ACUTA for a full year – this blog started about two weeks after I joined the company. From that first post, we’ve been reminding you that the electronic Common Technical Document (eCTD) – the way of packaging up everything from the thousands of documents to get a drug approved, or just …

ACUTA, ARCS, ARIM, ARIM Publisher, FDA, Software Release, Validator

Getting your STF in order

In 2003, ICH introduced the Study Tagging File (STF) in the electronic Common Technical Document (eCTD) format for electronic submissions to facilitate a way to associate all the documents and data files for a study. Initially the specification included two possible approaches for versioning the study’s items: Cumulative: A complete cumulative STF would be provided …

ACUTA, ARIM, Australia, Canada, eCTD, South Africa, Validator

ARIM 2.3.3 hotfix 11 and ARIM Validator 3.2 Released: Canada, Australia, South Africa updates

ACUTA has released new versions of ARIM 2.3.3 Hotfix 11 and ARIM Validator 3.2 (desktop). The primary features included in this release are: Support for South Africa (ZA) Validation specifications v2.1 Support for Australia (AU) v3.1 Validation and eCTD specifications. Support for Canada (CA) Validation specifications v4.2 Other cool enhancements: The license key can now …

ACUTA, APT, ARCS, ARID, Conferences

Forum Exchange: Come visit ACUTA at Booth 310 at the DIA RSIDM Conference, February 5-7

The annual Drug Information Association Regulatory Submissions, Information, and Document Management Forum (DIA RSIDM, for short) is February 5-7 in Bethesda Maryland. Come meet members of ACUTA’s product and business development groups, including Don Palmer, Director of Product Strategy Scott Higgins, Business Development Manager Joel Finkle, Director Regulatory Innovation Shylendra Kumar, President and CEO We …

ACUTA, ARCS, ARIM, eCTD, EMA, FDA

Your Holiday Gift: eCTD for Everything

A month ago, we reminded you that electronic Common Technical Document (eCTD) will be the rule for all US drug submissions on May 5, 2018, adding Master File and Investigational New Drug applications to the already-required New Drug Applications. What I’d neglected to mention is that eCTD is also expanding in 2018 for European submissions. …

ACUTA, ARCS, ARIM, eCTD, FDA

Six Months until Mandatory eCTD for INDs, DMFs at FDA

Almost seven months ago, I posted my first ACUTA blog entry on the FDA requirement for eCTD for all marketing applications, a little under a month before the May 5, 2017 deadline. The sky didn’t fall, companies didn’t fold for being unable to comply… and ARCS (ACUTA Clinical & Regulatory Services) helped numerous companies achieve …

ACUTA, ARCS, ARIM, Australia, eCTD, NeES

E-Submissions Looking Up Down Under

Australia’s Therapeutic Goods Administration (TGA) released updated guidance for both eCTD (electronic Common Technical Document) and NeES (Non-eCTD Electronic Submissions). Version 3.1 of the Australian regional eCTD specifications, and version 2.0 of the NeES specifications will be accepted starting January 1, 2018, and will be mandatory July 1, 2018. Because the eCTD and NeES are …