With REGISLATE™, manufacturers can dramatically reduce the time-to-market and cost of licenses for their products and can easily manage regulatory submissions for multiple products of all types in over 100 countries worldwide.
REGISLATE™ is your comprehensive solution for the establishment and operation of a global regulatory affairs department that will allow you to:
- Collect all regulatory and compliance documents in one location, under one accessible online management system for all types of products;
- Control the placement and assignment of each document used in the past for future product market approval applications in every market;
- Initiate new, updated, and/or renewed product approval applications in each and every country;
- Achieve all of the above faster and more cost-effectively than ever before through as much as 50% increased efficiency in the overall approval process, cost, and expedited time-to-market.
HOW DOES IT WORK?
Once your REGISLATE™ Corporate account is set-up, it’s easy.
- The manufacturer initiates a registration application with any agency and/or country;
- The system generates a portal for the manufacturer and opens applications for each product undergoing registration;
- The manufacturer assigns employees as needed, and they can review registration requirements in the portal and upload compliance documents accordingly;
- Internal regulatory affairs/product compliance experts, reviewers, and/or external experts are assigned to review the application documents. Deficiencies are communicated to the relevant people through the portal;
- When the registration process is complete, a pre-market submission is prepared, which can then be sent to the relevant authorities;
- A renewal notification is automatically sent to the manufacturer when the license needs to be renewed or changes in the regulations are implemented.
A SINGLE, CUSTOMIZABLE REGULATORY MANAGEMENT SYSTEM
REGISLATE™ takes the online product registration system LICENSALE.COM™ to the next level, bringing complete customizable control to your company’s regulatory affairs department. Not only can the system be tailored to support specific product compliance profiles, assigned privileges within user portals, project statuses, and full project management supervision, but special modules can be added as needed (e.g. post-marketing surveillance and recalls, link information with Customs Control, UDI, etc.)
Through REGISLATE™, your regulatory team can manage complex multiple product and country application processes in parallel and all your information, documents, and records are consolidated and accessible in a secure, cloud-based portal.
UNPRECEDENTED ADDED VALUE
With REGISLATE™, the Regulatory Affairs Department can become a strategic, proactive division of Sales and Marketing, finally gaining control over the registration process in each market throughout the complete regulatory lifecycle.
- The legal department regains control of intellectual property;
- The VP of Sales is released from their dependency on local distributors;
- The Business Development Manager can gain access to any new market in advance without the need for any prior presence or investment.
ACCESS THE BEST REGULATORY INTELLIGENCE
REGISLATE™ provides your regulatory affairs experts with immediate access to regulatory intelligence by product and country for over 100 countries worldwide. Once the information has been uploaded with REGISLATE™, the review process can be carried out by any of your own organization’s reviewers or any external experts you may choose to assign to particular compliance document, with full permissions control.
Integrate your institution into the global regulatory sphere through compatibility with LICENSALE.COM™
REGISLATE™ is fully compatible with LICENSALE.COM™, which is used by hundreds of medical device manufacturers worldwide to submit their files to international agencies.
According to your need, you can engage an Arazy Group expert in part or in full to assist with the registration of your products in new or existing markets. Documents uploaded with REGISLATE™ are matched seamlessly with product compliance criteria set up in LICENSALE.COM™.
Do you have questions about REGISLATE™ Corporate? Fill out the form below and an Arazy Group representative will contact you promptly.