Qualio
Qualio unifies QMS workflows with real-time compliance intelligence — giving quality and regulatory teams one place to manage documentation, training, deviations, CAPA, audits, and regulatory obligations.
Where basic eQMS tools stop at record-keeping, Qualio continuously assesses quality data against FDA, ISO, and EU MDR requirements to show where compliance is drifting before it becomes a finding.
Key Capabilities
Document and change control
Training and competency management
Deviations, nonconformances, complaints, and CAPA
Internal/external audit and inspection management
Compliance dashboards and hotspot alerts
Product/site-level risk visibility and regulatory mapping
Rapid deployment and validation support
Business Outcomes
✔️ Audit ready in weeks
✔️ Inspection ready anytime — no fire drills
✔️ Lower total cost of compliance
✔️ Confident, risk-managed scaling
Designed for MedTech, pharma, and biotech companies in growth mode.
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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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H1
H1 Universe is an innovative platform that leverages artificial intelligence to enhance the management of healthcare data, offering users access to the most extensive global database of healthcare providers (HCPs). By merging information from various sources, such as public, private, and proprietary databases, H1 Universe provides valuable insights that are crucial for clinical trials, medical affairs, and commercialization efforts. This powerful tool enables healthcare teams to pinpoint essential stakeholders, refine clinical research processes, and make informed decisions swiftly, ultimately boosting overall efficiency within the healthcare landscape. Furthermore, the platform not only aids in real-time decision-making but also fosters collaboration among healthcare professionals, paving the way for improved patient outcomes.
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Infor PLM Optiva
Infor PLM for Process (Optiva®) is tailored for manufacturers in the food, beverage, chemicals, and life sciences sectors, delivering a consolidated view of data and processes across different departments. This solution simplifies the journey to achieve compliance with regulations and labeling, whether by fulfilling reporting obligations, adhering to labeling standards, or providing ingredient transparency. With strong project management features, it ensures that all stakeholders have access to crucial project information throughout the stages of concept, development, and final approval. Reckitt Benckiser (RB), a prominent British multinational in consumer goods, leverages Infor® PLM for Process to enhance global safety and compliance initiatives while establishing a single source of truth regarding its product lifecycle from development to production. Furthermore, the integration capabilities with ERP systems allow for improved understanding of costs, thereby streamlining decision-making processes and enhancing overall operational efficiency. This comprehensive approach not only aids in compliance but also fosters innovation and improves product quality.
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