Press Releases

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The latest release of ACUTA PDF Tools is now available!

ACUTA is pleased to announce the release of version 4.1 of ACUTA PDF Tools. Highlights of New Features and Functionalities in 4.1: • TOC Generator Wizard: A new tool that enables users to create Table of contents in PDF documents without TOC. The TOC can be created from existing bookmarks or manually entering TOC items. Header and Footer for TOC page is also supported. • PageStamp Wizard: A new tool that enables users to stamp page numbers, as well as headers and footers without affecting existing headers and footers. • DocLink Wizard: A new tool that enables users to create external hyperlinks with file name extensions (sas, xpt, txt, xml, pdf) for the active document or for multiple documents. • TextLinker Wizard: A new tool that enables users create internal and external hyperlinks for keywords using ‘Select Region’ & ‘Add Prefix’. Users can then create bookmarks from the hyperlinked keyword. • And many other updates/enhancements.

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ACUTA’s ARIM 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) since the release of ARIM version 2.3.3 in 2016, we can now say we’re official, in that the Australian agency has recognized our efforts. We are proud to say that TGA has listed us among the “validation tools which may be used to ensure submissions are acceptable.” You can download a trial of current version (3.2.0 at the time of this writing) of the desktop ARIM Validator, and the same validation capabilities are found within the ARIM system which can be executed from the cloud or installed on-premise.
Shy Kumar, President and CEO of ACUTA, said, “This recognition from TGA is the result of our team’s hard work and our end users feedback. This enables our customers to have a trusted source for submission quality in the ARIM suite and ACUTA Validator.”

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ACUTA announces the release of version 1.0 of the ACUTA Regulatory Intelligent Documents (ARID) Template System.

ACUTA announced the release of ACUTA Regulatory Intelligent Documents (ARID) version 1.0 – a system of templates and productivity and quality automation for Microsoft® Office Word.
ARID includes over 250 shell documents designed to provide a starting point for the regulatory content needed for the Common Technical Document (CTD)- and Clinical Trial Authorisation (CTA)-based submissions sent to regulatory agencies. It also provides a focused ACUTA toolbar tab in Word that combines the most commonly used features from Word’s other tabs with new features specific to regulatory documents. ARID arrives at a great time for bio/pharma companies, when the number of vendors supporting regulatory templates has been dwindling.

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ACUTA announces the release of ACUTA Regulatory Information Management (ARIM) v3.1

ACUTA announced the release of ACUTA Regulatory Information Management (ARIM) version 3.0.1 – a next-generation solution that redefines how Life Science companies manage regulatory information.
Version 3.1 builds on the technology shipped in ARIM 3.0 to deliver a pure browser-based experience, without requiring platform plug-ins such as Java or Silverlight. The Version 3 platform also includes the Registrations Tracking Module, a master repository for product and registration data, to plan and track the global marketing status of products; Paper Publishing; and Side-by-side PDF document viewing. Don Palmer, Director of Product Strategy, had this to say: “With this release, ARIM reaches a new level - adding more functionality and making the system simpler to implement and use.”

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ACUTA announces the release of ACUTA Regulatory Information Management (ARIM) v3.0.1

ACUTA announced the release of ACUTA Regulatory Information Management (ARIM) version 3.0.1 – a next-generation solution that redefines how Life Science companies manage regulatory information.
ARIM brings together the data, content, and interactions with agencies needed to deliver a fully informed Regulatory Information Management (RIM) solution. Designed to work in the cloud or on premise, ARIM provides a centrally coordinated user experience while ensuring compliance. It supports the processes of Regulatory Affairs and Operations, regardless of their complexity or geographic location, and offers global access. “At ACUTA we follow a User-centered design process. We involve our end users in all aspects of product development. This release is a classic example as the key features introduced in this release are the result of that effort.” said Shy Kumar, ACUTA’s Founder, President and CEO. “Our goal is to keep our users happy, we work very closely with our customers, listen to them and try to bring in features and functionalities they need on a day to day basis.”

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ACUTA BLOG

ACUTA announced today the launch of ACUTA BLOG which will be an interactive site keeping you informed of regulatory news and trends. The blog is located at http://blog.acutallc.com or Click Below

ACUTA BLOG
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ACUTA announces the release of ACUTA Regulatory Information Management (ARIM) v3.0.0

ACUTA announced the release of ACUTA Regulatory Information Management (ARIM) version 3.0.0, a next-generation solution that redefines how life science companies manage regulatory information.
“ACUTA’s goal is to offer this next generation RIM solution to enable companies of all sizes to adhere to strict standards set by regulatory authorities around the world, and help them collect and manage regulatory information with reliability” said Shy Kumar, ACUTA’s Founder, President and CEO. “With this release we are very proud to announce the introduction of the Registrations Tracking module! ARIM users now have the opportunity to plan and track their marketing and investigational applications around the world. This release also offers the capability to publish Paper submissions for agencies still accepting paper, which is another critical requirement to support Rest of World (ROW) submissions.”

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ACUTA announces the release of ACUTA Regulatory Information Management (ARIM) v2.3.3 and ACUTA Validator v2.3.3

ACUTA announced the release of ACUTA Regulatory Information Management (ARIM) version 2.3.3, a next-generation solution that redefines how life science companies manage regulatory information, and ACUTA Validator v2.3.3, a desktop based application to support stand-alone validation of eCTD and NeeS submissions.
“ACUTA’s goal is to offer this next generation RIM solution in a timely manner to enable companies of all sizes to adhere to strict standards set by regulatory authorities around the world and help them collect and manage regulatory information with reliability” said Shy Kumar, ACUTA’s Founder, President and CEO. “This release is focused on providing support for the upcoming EU regional DTD v3.0 requirements, that go into effect from July 1, 2016 and will become a requirement from October 1, 2016. ”

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ACUTA ARIM v2.3.2 is now available

ACUTA, a leading cloud based solution provider to the life sciences industry, today announced the release of ARIM v2.3.2.

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ACUTA announces the release of ACUTA PDF Tools version 3.0.0

ACUTA, a leading cloud based solution provider to the life sciences industry, today announced the release of ACUTA PDF Tools v3.0.0. Exclusively designed for the Life Sciences and related industries, ACUTA PDF Tools will help users prepare and publish PDF files very efficiently. ACUTA PDF Tools eliminates tedious manual processes and offers significant savings in time and cost involved in preparing PDF documents for regulatory submissions to any agency in the world in any dossier format (eCTD, NeeS or just PDF submission).

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ACUTA announce the release of ACUTA Regulatory Information Management (ARIM) version 2.2.0

ACUTA announced the release of ACUTA Regulatory Information Management (ARIM) version 2.2.0 – a next-generation solution that redefines how life sciences companies manage regulatory information. ARIM brings together the data, content, and interactions with agencies needed to deliver a fully informed Regulatory Information Management (RIM) solution. Designed to work in the cloud or on premise, ARIM provides a centrally coordinated user experience while ensuring compliance. It supports Regulatory Affairs and Operations processes regardless of their complexity or geographic location, and it offers global access.

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ACUTA Introduces Regulatory Information Management (RIM) Solution for Life Sciences

To an audience of more than 300 attendees at the DIA EDM and ERS 2014 Conference, ACUTA unveiled ACUTA Regulatory Information Management (ARIM) – a next-generation solution that redefines how life sciences companies manage regulatory information. ARIM brings together the data, content, and interactions with agencies needed to deliver a fully informed Regulatory Information Management (RIM) solution. Designed to work in the cloud or on premise, ARIM provides a centrally coordinated user experience while ensuring compliance. It supports Regulatory Affairs and Operations processes regardless of their complexity or geographic location, and it offers global access.