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.”
Please contact ACUTA for additional information on software for regulatory submissions, and how we can help you get to compliance with the eCTD in Australia and the rest of the world.