Benjamin Arazy, President & CEO, Arazy Group Consultants Inc
MedTech products are rapidly evolving with the advancement of technology to become more personalized and connected. But against this backdrop of continual innovation, medical and IVD devices companies face unique challenges to get their products into the market due to the complex regulatory landscape. To have their products approved for market entry, these companies need to go through a cumbersome process of license submissions and maintenance in multiple countries, facing different regulatory frameworks, and requirements.This is an expensive, time-consuming, and resource-intensive process as it needs to be repeated in each new market for any new product and throughout the product lifecycle. This causes unnecessary delays in product registration and market access approval.
Arazy Group Consultants Inc, a global, multifaceted regulatory affairs firm helps medical and IVD device companies to accelerate their time to market through its award-winning regulatory solutions. Arazy Group began its journey as the first medical and IVD device regulatory affairs consultancy in Israel with a focus on providing regulatory and quality assurance compliance services to the young Israeli medical device industry. Over time, it evolved to become a global service provider following the development of the first regulatory affair technology product: LICENSALE that was launched in 2013. Today, it stands tall as an international consultancy spanning several continents, assisting medical and IVD device companies with regulatory compliance and affairs as they try to enter new markets.Headquartered in Vancouver, British Columbia in Canada, currently, the company is providing services in 140 countries.
“Using our technology, companies significantly improve their regulatory process and effectively manage the global market access for existing and future products. Our products and services connect medical device manufacturers, regulatory authorities, and industry experts through one global regulatory management platform,” explains Benjamin Arazy, the President and CEO of Arazy Group.
Improving the Global Licensing and Registration Process
Leveraging its decades of experience and the latest advancement in technology, Arazy Group has developed an integrated suite of cloud-based products to eliminate the redundancy found in the current international Medtech registration and market access practice. With the introduction of LICENSALE®, an all-in-one global regulatory affairs platform, Arazy Group took the lead on the provision of advanced registration and license management technology solutions. Since its official launch in 2013, LICENSALE® has processed thousands of product registrations, world-wide. In April 2020, the company released LICENSALE® 2.0platforms , the next generation of LICENSALE® which includes ready-to-use medical and IVD device registration applications which are prepared and submitted by Arazy Group experts. Having a unique GR-MAP™ for market analysis & planning, and real-time registration management and reporting,LICENSALE® 2.0platforms stands out as the most advanced system for MedTech regulatory affairs available on the market.
Besides this, Arazy Group also offers REGISLATE®, the first dedicated global regulatory management system that enables its client to effectively optimize their regulatory workflow. In addition to the advantages that comewith LICENSALE®, REGISLATE® also offers the ability to medical device companies to initiatemultiple registration activities in any market and engage internal and external regulatory resources of their choice while remaining in full control of their registration processes, compliance documents, and timeline.
Equipped with such pioneering solutions, Arazy Group provides the medical and IVD device companies with three key benefits—faster time-to-market, reduced costs, and license ownership.Compared to distributors or local consultants, its LICENSALE® 2.0platforms only require 25% of the working hours invested in obtaining market clearance. This accelerates the time to market for medical and IVD device companies and results in increased sales revenue. It also reduces the overall regulatory costs of the companies by as much as 50 percent while allowing them to take full control of their regulatory affairs and gain medical and IVD device approvals in 140 countries
“Being a leader and inventor of global Medtech registration technology, Arazy Group is continuously striving to accelerate time-to-market for faster and equal public access to advanced MedTech products on a global scale,” says Benjamin.
Committed To Accelerate the Global Accessibility of Medtech Devices
Since its inception, Arazy Group’s mission has been to make the best medical devices and medical practices available to patients and physicians around the world. Staying true to this vision, the astute team at Arazy Group has been relentlessly working together to improve health care through advanced regulatory affairs practice. The company’s strong commitment torealizing this vision has been reflected in many wins it had over the years. For instance, it helped Orasure Technologies, a leading vitro diagnostics company in the USto introduce an advanced HIV self-test solution to multiple countries. Sponsored by the prestigious Bill and Melinda Gates Foundation for over 20 million dollars, this project needed registration in several countries especially in sub-Saharan Africa where regulation is extremely complex or non-existent. With the help of Arazy Group, today the product is available to the physicians and patients in more than 40 countries. Amid this ongoing Covid–19 pandemic, these self-test kits are providing a great alternative to visiting a clinic for HIV testing.
“We encourage everyone involved in bringing Medtech products to market implement the best practices to ensure their products are equally available for everyone in the fastest and most efficient way,” asserts Benjamin.
Continues Addressing the Regulatory Challenges in the Industry
Forging ahead,Arazy Group aims to continue leveraging technology to meet its client’s expectation and address new challenges that new Medtech technology and the ongoing changes in the regulatory landscape are placing on the industry.
“We are delighted to see how well our products are being accepted and adopted by the industry and we will continue to strengthen our position as the leader of Medtech regulatory affairs technology,” adds Benjamin. The company also plans to expand its role as the leading player in the field of regulated product registration to other industriesincludingcosmetics and food supplements sectors.