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 …

Conferences, Uncategorized

DIA Canada October 16-18

Sorry for the short notice, but please come hear me present IDMP: International Data, Multiple Processes at the DIA Canada annual meeting in Ottowa October 16-18. I will be speaking in session 4C at 3:30PM on October 17, in the session Identification of Medicinal Products (IDMP)- Updates and Implementation Approaches, chaired by Maggie Graham of Health …

Brexit, EMA

Brexit Update: EMA Prefers Amsterdam

This is just a quick update on the status of the move of the EMA headquarters from London, due to the UK leaving the European Union, generally known as Brexit. The IDMP “SPOR” Master Data Management project at EMA is expected to be delayed due to the move, but IDMP is the only project known …

ACUTA, ARIM, ARIM Publisher, eCTD, EMA, FDA

Lots of Regulatory Activity Going On

Welcome to another episode of Fun With RIM (kidding, this is the first one). Today’s topic: Just what is a Regulatory Activity? You’ll say to yourself, “I’m in Regulatory, and I do things, so those must be Regulatory Activities.” Not counting that 15 minutes to two hours that half the workforce spends every day on …

ACUTA, ARIM, Software Release

ACUTA Ships ARIM 3.1, ARIM 2.3.3 and Validator

As you can see in the photo above, we have been putting tremendous effort toward shipment of the latest releases of the ARIM (ACUTA Regulatory Information Management) system. Shy Kumar, Founder and CEO of ACUTA, said this of the new releases: The ACUTA team continues to innovate with a focus on bringing new capabilities and …

ACUTA, APT, ARIM Publisher, eCTD

PDF Links Feel So Broke Up, I Want to Go Home

PDF in Electronic Submissions Before there was eCTD (the electronic Common Technical Document), there were submissions using just PDF – the Portable Document Format created by Adobe (and before PDF, there were submissions using interactive PostScript, TIFF images, DAMOS, etc., but that’s a scary story for another time, perhaps around a campfire) The PDF file …

CMC, FDA, IDMP, XML

FDA’s Draft CMC Data Elements – IDMP’s New Buddy?

On July 5, 2017, FDA (United States Food and Drug Administration) published a new document to the Federal Register titled “Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Technologies.” This is a draft document describing data structures that could take the place of much of the eCTD (Electronic Common Technical Document). Public comment is …

Brexit, EMA

What does Brexit mean for Pharmaceutical Companies?

The whole world is holding its breath to see whether Britain’s withdrawal from the European Union, nicknamed “Brexit,” will have a “hard” landing – meaning a strict break with the European common market and open emigration – or a “soft” one, meaning that some parts of the treaty may be maintained. Theresa May, Prime Minister, …

ACUTA

ACUTA Expands to Philadelphia Area

Barely two months after moving its headquarters to a larger office in Marlborough, Massachusetts, ACUTA has opened its second US office on July 26, 2017, in Bensalem Pennsylvania. Founder and CEO Shylendra Kumar expressed his excitement on the occasion of opening the new office: The growth of ACUTA continues, and this new office will allow …

ARIM Registrations, EMA, IDMP, XEVMPD

XEVMPD: Unpacking its impact on IDMP

Note: This article is not a commitment to features or capabilities of ACUTA products or services. When ACUTA added the Registration module to to ARIM version 3.0 in 2017, our expectation was that IDMP (Identification of Medicinal Products, the ISO standards being implemented first in Europe) was imminent. Because of that, we expected it would …