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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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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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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Essenvia
Essenvia enhances business value and improves operational efficiency across various teams and departments. It serves as a centralized hub for all regulatory data, facilitating collaborative document creation and reporting while helping to prevent technical holds, RTAs, and RFIs. This platform empowers the regulatory affairs team to speed up product launches, thus avoiding revenue losses associated with submission delays and missed renewals. It provides a comprehensive overview of the entire regulatory lifecycle, complete with executive dashboards, key performance indicators, and proactive alerts for global registrations, submissions, and change assessments. Essenvia acts as a Regulatory Information Management (RIM) Platform that streamlines regulatory workflows throughout the entire product lifecycle, enabling faster global market access and delivering significant business advantages. By consolidating all regulatory activities into one unified platform, businesses can accelerate their market entry. Additionally, it includes a central repository for all registration documents, which are linked to product master data, allowing users to effectively manage the product registration lifecycle on a country-by-country basis while ensuring compliance and efficiency.
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