Used by regulatory affairs professionals worldwide
Medical Device and IVD
Registration Management Platform
Arazy Group Medical Device Registration and Regulatory Technology
The company behind the first ever regulatory management system for
IVD and medical device registration.
When Arazy Group launched LICENSALE® – Global Medtech Registration System in 2013, we became the first company to offer advanced medical device registration and license management technology specifically for the medical and IVD device industry.
LICENSALE® has since delivered thousands of new IVD and medical device registrations, amendments, renewals, and transfers of licenses, staying true to our company mission to make the best medical devices and medical practices available to patients and physicians world-wide.
26
2,300
4,400
LICENSALE® 2.0 – Global IVD and Medical Device Registration Platform
Leveraging on our experience and the latest advancement in software, database management, machine learning and A.I., we developed the next generation in IVD & medical device registration and license management software- LICENSALE® and REGISLATEⓇ.
Device-Specific Registration Applications With Pre-Population
“As a Regulatory Affairs professional, I love LICENSALE because the system generates accurate device-specific registration applications in each country and prepopulates it with compliance documentation that we already have from previous submissions. I no longer need to look for regulatory information or spend time on repeated tasks when preparing new applications. LICENSALE® takes care of all of that for me. The time saved allows me to manage many more registrations than otherwise would have been able to.”
Real-Time Product Market Status and Registration Progress Dates
“As a Director of Regulatory Affairs, LICENSALE® provides me immediate access to each product’s market status in real-time. I no longer need to ask for that information from my regulatory team. The global regulatory map presents a quick yet detailed overview of the current registration stage and estimated submission and approval dates for all registrations in progress.”
Team Collaboration and Global Project Management
“As a VP of regulatory affairs, LICENSALE® is a tool that allows me to manage all our registration activities worldwide. My team collaboration with internal and external resources is well documented and visible throughout the submission file preparation. LICENSALE® provides a country-specific process that matches the registration activity in each country. It makes is easy for my team to update the project progresses, and for me to monitor each step, and intervene when needed. By becoming more efficient, we can save a lot of money and address additional activities which otherwise would have to wait for next year’s budget.”
Market Planning and Analytics Right at Your Fingertips
“As the International Sales Manager, I can access LICENSALE® via my cell phone wherever I go. I can see when the product will be available in the market even before finding a local distributor or when we want to participate in an upcoming tender. The system’s analytics allows me to plan for future market access and asses our Market Readiness Index for every product in each market.”
Independent License Ownership
“As the CEO of a MedTech company, what I like about LICENSALE®‘s robust and sustainable platform is that it allows us to continue our regulatory work uninterrupted and ensure our products are available in all markets and accessible for those who need them. I particularly love that we no longer need to negotiate the registration process as part of the contract with the distributors. LICENSALE® allows us to be completely independent in obtaining and owning the license if we chose to do so.”
Expand Your Consulting Offering to New Markets
“As a regulatory affairs consultant, LICENSALE® enabled me to grow my practice after only a few hours of training. I am now able to offer my existing clients registration management in additional markets. Without LICENSALE®, I had to significantly dependent on third parties for regulatory expertise for these countries, or they were simply out of reach.”
Bringing the Best Medical Device and Practices to Patients Around the World
practitioners using our regulatory affairs solutions.
