Samarind RMS Version 4 Released
Samarind announces the latest version of its award winning regulatory software.
Samarind Limited, a leading provider of software to the regulatory affairs profession, announces the release of the 4th generation of its award winning regulatory affairs management software, Samarind RMS for Windows.
This latest version of the software features a number of key enhancements including support for US, Canada and Asia Pacific submission procedures, support for International character sets in trade names
enhanced management of PSURs, enhanced alerts and notifications, and enhanced management reporting.
Samarind's development roadmap also includes an update to the system's existing EudraVigilance Medicinal Product Dictionary (MPD) automated upload facility, to ensure it meets the requirements of the pending EU mandate for EVMPD updates, announced by the EMA on 1st July. This legislation requires the submission of medicinal product information for all authorised product in Europe by 2nd July 2012 - less than 12 months away. Samarind is already seeing renewed interest in this feature of its software, as many companies are looking to submit their information well before the deadline.
Also in the development roadmap is support for medical device registrations. This functionality is planned for release in 2012.
Samarind's Phil Turner commented, "Our objective remains to ensure that we align our software with the current and future needs of the regulatory affairs profession. When we originally developed Samarind RMS, it was primarily focused on supporting pharma companies in the European market; however with our continued success and growing interest levels in our software from companies around the world, we've gradually developed the system based on a wider remit. This latest version firmly establishes RMS as a global system.
"To some extent we approached the market from a different angle to other software vendors, with RMS being predominantly a submissions tracking database from the outset. But having working closely with our customers over the years, we've gradually introduced a wider set of features (including eCTD tools) without compromising the integrity of the original concept for the software. What we've achieved is a genuinely integrated regulatory system that remains very flexible.
"What's interesting is that the market seems to be coming towards us a little more, with some of the software's original concepts/features becoming must have, rather than nice to have. A good example of this is the recently announced EU mandate for EVMPD, which means the submission of information on all authorised products in the EU will become mandatory from 2nd July 2012. Samarind RMS has had a feature to support automated EVMPD updates since October 2005, which demonstrates our innovative approach to solving challenges presented by the industry. Whilst EVMPD is essentially a pharmacovigilance issue, it's something that regulatory affairs departments have a stake in, simply because it's relevant to any current (EU) product licences. We are actively working with our existing customers to be ready in advance of the newly announced system to ensure compliance with the EU mandate.
"Our next significant development will be supporting registrations in the devices market, and again we're working with both existing and prospective customers to ensure Samarind RMS V4 meets global regulatory requirements for both devices and pharma companies. We welcome enquiries from any medical device companies at this stage."
Samarind RMS helps to reduce the costs of managing your licence portfolio, and maximises the potential revenue and profitability of your licences. For further information or to arrange a demonstration, contact us today on +44 (0) 1244 288281 or click here.