DÜSSELDORF, GERMANY (NOVEMBER 14 2014): Following the successful implementation and operation of LICENSALE.COM™ since its launch at MEDICA 2012, Arazy Group Consultants Inc. introduced the next phase in its suite of integrated cloud-based products designed to streamline, simplify, and expedite international regulatory affairs. Officially launched at Medica on November 14th 2014, REGISLATE™ is the first dedicated global regulatory management system for the large-scale processing, submission, and review of regulated product applications.
Directed to manufacturers as well as government agencies or other professional organizations, the customized SaaS platform builds on 20 years of Arazy Group consulting experience to create a simple-to-use, intuitive system that completes the regulatory infrastructure needed for the effective operation of a regulatory department or organization. REGISLATE™ users are able to control, manage, and process the review and licensing of regulated products on a large scale and according to the needs of the particular organization. REGISLATE™ does not only dramatically increase efficiency and construct a customizable, cloud-based regulatory infrastructure, but also benefits from other Arazy Group services, allowing for the integration of compliance expertise and review based on either internal or external resources, including Arazy Group’s extensive global expert network.
The operation concept of REGISLATE™ has already been in use for over two years through Arazy Group’s online product registration system, LICENSALE.COM™. LICENSALE.COM™ is successfully processing thousands of applications for medical and IVD device manufacturers of all sizes worldwide, including multinational MedTech companies like Elekta, Physio Control, Toshiba, SPD, Luminex, FujiFilm Sonosite, P&G, T-DOC/Laborie, C Bard, and more.
“The success of LICENSALE.COM™ prompted us to look at large-scale options to accommodate the needs of both clients and the market,” said Arazy Group President and CEO Benjamin Arazy. “Our system has been proven as an effective tool for the administration and submission of medical and IVD device applications, significantly reducing overall approval times and cost in over 100 markets. REGISLATE™ marks the next growth phase of LICENSALE.COM™, serving the needs of both manufacturers and regulatory authorities as a fully-customizable regulatory submission management system.”
The tailored REGISLATE™ system is available in two versions:
REGISLATE™ Corporate allows manufacturers processing large quantities of regulatory submissions to manage their submissions and licenses in a flexible, comprehensive, cloud-based application. Manufacturers are able to reduce the time-to-market and cost of licenses for their products while easily managing regulatory submissions for multiple products of all types in over 100 countries worldwide, all with the support of the latest regulatory intelligence.
REGISLATE™ Government is the comprehensive solution for the establishment and/or operation of a government agency or professional organization responsible for domestic regulation and approval of regulated products such as medical devices, pharmaceuticals, and foods. In addition to the administration features of REGISLATE™, REGISLATE™ Government users benefit from the ability to define regulatory policies by device and classification within the system, publish the policies so that they are accessible to applicants, collect fees during the review process, and issue certificates as required.
REGISLATE™’s proven technology sets the stage for the next phase of Arazy Group services, bringing innovative regulatory practices and resources to manufacturers and agencies alike, worldwide.
About Arazy Group Consultants Inc.
Arazy Group Consultants Inc. is a global regulatory affairs firm providing technology services and products designed to streamline, simplify, and expedite international regulatory affairs for all types of medical and IVD devices. With 20 years of experience in the successful registration of thousands of medical devices around the globe, our service technology tools, customized management software, and integrated expert network optimize planning, process control, and resource management for the entire product regulatory life-cycle. Arazy Group is based in Vancouver, British Columbia, Canada. To learn more about Arazy Group, visit our website.
350-1333 Johnston St., Granville Island
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Tel: +1 604.681.6888