RegDesk
RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies.
• Our proprietary Regulatory Intelligence for over 120+ countries is translated and accessible in a standard format. In addition, it provides alerts on evolving regulatory changes
• Our AI-powered Application Builder allows RA teams to prepare and publish global applications in 1/10th of the time
• Our Change Assessment capability helps RA teams understand the impact of the change(s) on an existing product(s) and the action required
• Our Distributor Collaboration provides seamless workflow solutions to interact, communicate, and share documents with external business partners
• Our Standards Management makes it easy for RA teams to search and manage not only international but also country-specific standards
• Our Tracking & Reporting functionality allows teams to track regulatory projects across the globe, receive renewal notifications, and generate reports on KPIs within seconds
For more information, visit our website.
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Pipefy
Pipefy is a low-code Business Orchestration and Automation Technologies (BOAT) platform designed to act as a modern middleware layer for the enterprise stack.
Rather than replacing existing Systems of Record (SORs) like SAP, Oracle, or Salesforce, Pipefy wraps them in an agile orchestration layer. This architecture allows technical teams to modernize legacy operations and extend the life of core systems without the risks associated with "rip and replace" projects. Pipefy provides the infrastructure to sanitize data inputs, manage complex business logic, and orchestrate API calls between fragmented endpoints.
Technical & Architectural Highlights:
• Adaptive Governance Framework: Pipefy solves the "Shadow IT" problem by establishing IT-sanctioned "Safe Zones." Business users can build workflows within these guardrails, while IT retains control over critical data, integrations, and permissions via a centralized console.
• Agentic AI Engine (BYOLLM): The platform features a governable AI Agent Studio. Unlike "black box" solutions, Pipefy supports a Bring Your Own LLM approach, allowing enterprises to integrate preferred models (Azure OpenAI, AWS Bedrock) securely to automate document analysis (OCR) and decision-making.
• Robust Connectivity: Built with an API-first philosophy, Pipefy offers a GraphQL API, Webhooks, and enterprise-grade iPaaS capabilities to ensure seamless data interoperability across the stack.
• Security & Compliance: Engineered for regulated industries, the platform is ISO 27001, ISO 27701, and SOC2 Type II certified, supporting compliance with GDPR and SOX standards.
Pipefy empowers IT leaders to eliminate technical debt and clear development backlogs by safely delegating low-complexity builds to business units.
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Rimsys
Rimsys provides a single, cloud platform for end-to-end regulatory process digitization and automation. Designed by and for regulatory affairs professionals, Rimsys helps medtech companies reduce repetitive administrative work, speed time to market, respond faster to changing regulations, and drive alignment across internal teams, affiliates, and partners.
Only Rimsys provides a holistic platform that supports a full range of regulatory activities. Use regulatory intelligence and digital templates to guide regulatory strategy and streamline submissions. Create compliant, submission-ready content, and consolide PDF packages for electronic and print submissions. Digitally collect and maintain evidence of compliance. Link to relevant standards and get notified of changes. Get notified of changing standards, laws, regulations, and guidance documents that impact your products. Create self-service application, product, and country reports to see exactly where your products can be sold and their current registration status.
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RIMTrack
In light of the constantly evolving national regulations and the intricate nature of preparing for regulatory submissions, organizations within the healthcare and life sciences sectors are increasingly focused on adopting smarter methodologies and intelligent systems to enhance efficiency, reduce costs, and shorten submission timelines. To tackle these challenges, RIMTrack emerges as a cutting-edge regulatory information management system that leverages cloud-ready artificial intelligence. Built from the ground up, its primary goal is to assist organizations in achieving precise and effective submission preparations while streamlining the various regulatory processes involved in tracking, licensing, approvals, regulatory and competitive intelligence, clinical trials, and comprehensive reporting across international stakeholders. By integrating seamlessly with existing Regulatory Information Management systems, RIMTrack facilitates a thorough end-to-end management of the entire regulatory lifecycle, ultimately empowering organizations to navigate the complexities of compliance with greater ease and accuracy. Such advancements not only improve operational efficiency but also position organizations to adapt more readily to future regulatory changes.
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