Rimsys
Rimsys is bringing regulatory order to the medtech industry. The Rimsys Regulatory Information Management (RIM) platform digitizes and automates regulatory activities, freeing teams from inefficient administrative work, and helping them confidently establish and secure global regulatory compliance. Unlike complex, color-coded spreadsheets, or expensive external consultants, Rimsys seamlessly centralizes all regulatory information, automates submission processes, and monitors relevant expirations, standards, and global regulations. Traditional approaches to regulatory affairs can’t keep pace with the growing complexity of the global landscape, and overburdened teams face increasing compliance risks. Rimsys streamlines all regulatory activities including registrations, essential principles, UDI, standards management, and regulatory intelligence in a single, integrated platform.
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Regislate
Everything you need to successfully register your medical device or IVD product in any market around the world and manage your market access license through the product life cycle. REGISLATE® provides users with medical and IVD device-specific at country-specific complete submission file requirements. Users can manage milestones, timelines and estimated and actual completion dates for initial registrations, renewals, amendments and license transfers in real-time. Infographic data and proprietary indicators for clear monitoring and management of each project are available. Utilize collaboration tools for preparation and review of submissions, compliance requirements and documents. Recieve progress reports in real-time for current and future submissions including market access readiness index. REGISLATE® includes GR-MAP registration tracking for both country and product.
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Pebl
Pebl (formerly Velocity Global) combines AI-powered technology and local, in-country expertise to simplify every aspect of global workforce management. From hiring and payroll to compliance and retention, we make it easy to grow your business across 185+ countries.
● Ensure global operations stay compliant with local laws and regulations in every market.
● Your employees are taken care of by our network of in-country HR, payroll, tax and legal experts.
● Manage your entire global workforce from one platform—reliable, seamless, and efficient.
● From startups to enterprises, our solutions scale as your business grows, adapting to your evolving needs.
● Cost Transparency: No hidden fees. Upfront, all-in-one pricing package with all services included and demonstrable lower total cost of ownership.
Pebl is recognized as Market leader in in Global EOR Services by NelsonHall and Everest Group.
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Essenvia
Essenvia drives business value and brings cross-functional efficiency gains to all teams and departments. Centralized repository for all regulatory information, enabling collaborative authoring and reporting while eliminating technical holds, RTAs, and RFIs. Empowerment of regulatory affairs department to accelerate product launches and eliminate revenue loss due to submission delays and missed renewals. Helicopter view of the total regulatory lifecycle. Executive dashboards, metrics, and proactive alerts for global registrations, submissions, and change assessment. Essenvia is a RIM Platform that enables you to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Consolidate your regulatory activities into one centralized platform and bring your devices to market faster. Central repository for all registration docs linked to product master data. Manage product registration lifecycle by country.
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