Qualio
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.
Learn more
HSI Donesafe
HSI Donesafe redefines EHS management with a no-code, cloud-based platform that transforms complex processes into streamlined, user-friendly workflows. Trusted across industries, Donesafe consolidates tracking, management, and reporting into one accessible platform, making compliance simpler and safety more effective.
Donesafe’s adaptable design allows teams to customize workflows, forms, and dashboards to meet evolving compliance needs. With tools for incident reporting, audits, training, and risk assessment, staying ahead of regulatory changes has never been easier.
Key Features:
- Customizable workflows to align with regulations
- Real-time insights for live safety tracking
- Scalable design that grows with your team
- Streamlined compliance tools for smooth audits and reporting
Empower your EHS team to achieve safety excellence with HSI Donesafe.
Learn more
PharmaPendium
PharmaPendium serves as a robust platform that grants users access to a wide array of FDA and EMA drug approval documents, encompassing essential aspects like pharmacokinetics, pharmacodynamics, and safety evaluations. This resource delivers in-depth insights into drug-drug interactions, side effects, and outcomes from clinical studies, thereby empowering stakeholders to make well-informed decisions during the drug development process and when making regulatory submissions. Its rich database aids researchers and healthcare practitioners in assessing both the efficacy and safety of medications, playing a pivotal role in the progression of pharmaceutical research and enhancing patient care. Users can explore historical regulatory submissions and leverage past precedents to better understand and anticipate agency requirements. The interface allows for a seamless transition from tabular data to dynamic charts, graphs, and other visual tools, making it easier to analyze and interpret findings. Additionally, users can search for information related to adverse events (MedDRA), therapeutic targets, drug indications, and endpoints utilizing standardized data. Result pages effectively connect preclinical research with clinical applications, facilitating a comprehensive understanding of the drug development landscape. Overall, this platform not only streamlines the research process but also fosters collaboration and knowledge-sharing among industry professionals.
Learn more
dezzai Sentria
Sentria is a cutting-edge platform that utilizes artificial intelligence to manage adverse event cases and conduct post-marketing surveillance. This software solution is user-friendly, highly customizable, and automated, ensuring it meets industry regulations to improve the efficiency, speed, and accuracy of adverse event handling. It supports pharmacovigilance compliance with international ICH guidelines while adhering to local regulatory requirements for the assessment of adverse events. By providing an easy-to-use interface enhanced with pharmacovigilance automation, Sentria minimizes reporting errors through smart alerts and simplifies report processing by employing international coding standards such as MedDRA and ATC/WHO. The platform enhances analytical capabilities through the use of semantic artificial intelligence tailored for pharmacovigilance needs. Notably, Sentria offers features like secure access controlled by user credentials, comprehensive auditable logs to ensure compliance, and a secure encrypted cloud environment for data protection. These functionalities collectively empower organizations to manage adverse events more effectively, contributing to better patient safety outcomes.
Learn more