
Qualio is a purpose-built quality and compliance platform for life sciences companies operating in complex, high-stakes regulatory environments. Medical device, SaMD, biotech, and pharma teams use Qualio to replace fragmented eQMS tools, spreadsheets, and consultant-driven audits with a single, validated system that delivers continuous audit and inspection readiness.
Qualio combines a modern eQMS with Compliance Intelligence—an AI-driven layer that continuously evaluates how well real operating data aligns with regulatory requirements. Instead of treating audits as one-off events, teams gain always-on visibility into compliance coverage, risk exposure, and readiness across FDA, ISO, EU MDR, GxP, and software-intensive standards.
Core quality workflows—document control, training, CAPA, change management, supplier quality, and design controls—are directly connected to regulatory obligations and objective evidence. Deep integrations with Jira, Azure DevOps, GitHub, TestRail, and Salesforce automatically capture proof from development and operational systems, eliminating manual evidence gathering and reducing compliance drag on engineering teams.
Compliance Intelligence runs multi-standard gap analysis in under an hour, flags emerging risks before they become findings or 483s, and maps reusable evidence across frameworks to accelerate submissions and market expansion. All insights are explainable and traceable back to specific clauses and internal policies, supporting validation and audit expectations.
The result: audit readiness in weeks instead of months, fewer fire drills, faster launches, and lower long-term compliance cost. Qualio turns compliance from a reactive burden into a predictable, scalable system.
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SDS Manager is a premier provider of SDS Management solutions, featuring one of the world’s largest SDS databases with over 14 million Safety Data Sheets in 25 languages.
With SDS Manager, employees can access essential SDS information directly from their mobile devices by simply scanning QR code posters in work areas where chemicals are used. This seamless mobile access promotes both safety and regulatory compliance.
Our automated data extraction feature lets you effortlessly add SDS files to your library without any manual typing, significantly improving accuracy and streamlining SDS management. Keep your SDS library updated, organized, and ready for quick access in a secure cloud environment.
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Substantio
The growing number of regulations that businesses must navigate is creating challenges and making the overall subject increasingly intricate. Substantio Software and Substantio Services are dedicated to establishing and executing a robust Substance Compliance process. With years of experience in the Substance Compliance field, our team has successfully completed numerous customer projects, leading to the development of best-practice methods that we continuously refine to provide top-tier solutions. You can easily report to SCIP with just one click. Our Substantio software, combined with the expertise of our seasoned team, will guide you in setting up your ECHA account, configuring S2S access, and importing your data into Substantio. Once this initial setup is complete, Substantio takes over, automating the process while you simply choose the components you wish to submit. Furthermore, Substantio automatically checks the inputted data against widely recognized regulations such as RoHS, REACH, and Proposition 65, among others, ensuring compliance without the hassle. This streamlined approach not only saves time but also significantly reduces the risk of errors in regulatory submissions.
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Adherent
Adherent is an AI-powered product compliance platform built for companies that need to manage constant regulatory change across global markets. The platform helps compliance teams monitor product regulations, assess regulatory applicability, identify compliance requirements, prioritize business risk, and support ongoing compliance decisions. Its agentic AI capabilities automate time-consuming work such as tracking regulatory updates, mapping rules to products, extracting obligations, and highlighting the most important risks. Adherent is designed for regulated enterprises that need transparency, auditability, explainability, and control in their compliance technology. The platform is powered by a proprietary foundation of human-verified compliance intelligence developed through nearly 25 years of regulatory expertise. Ari, Adherent’s AI product compliance assistant, helps execute compliance workflows so human experts can spend more time on strategy and decision-making. The platform supports real-world compliance challenges across roles, policy areas, industries, sustainability requirements, product requirements, evidence management, standards management, and regulatory intelligence. Adherent serves industries such as apparel, automotive, consumer electronics, cosmetics, household appliances, industrial machinery, medical devices, online retail, power tools, garden machinery, and toys. Adherent helps companies accelerate global compliance, reduce manual assessments, improve regulatory visibility, and make product compliance more scalable.
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