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.
Learn more
StackAI
StackAI is an enterprise AI automation platform that allows organizations to build end-to-end internal tools and processes with AI agents. It ensures every workflow is secure, compliant, and governed, so teams can automate complex processes without heavy engineering.
With a visual workflow builder and multi-agent orchestration, StackAI enables full automation from knowledge retrieval to approvals and reporting. Enterprise data sources like SharePoint, Confluence, Notion, Google Drive, and internal databases can be connected with versioning, citations, and access controls to protect sensitive information.
AI agents can be deployed as chat assistants, advanced forms, or APIs integrated into Slack, Teams, Salesforce, HubSpot, ServiceNow, or custom apps.
Security is built in with SSO (Okta, Azure AD, Google), RBAC, audit logs, PII masking, and data residency. Analytics and cost governance let teams track performance, while evaluations and guardrails ensure reliability before production.
StackAI also offers model flexibility, routing tasks across OpenAI, Anthropic, Google, or local LLMs with fine-grained controls for accuracy.
A template library accelerates adoption with ready-to-use workflows like Contract Analyzer, Support Desk AI Assistant, RFP Response Builder, and Investment Memo Generator.
By consolidating fragmented processes into secure, AI-powered workflows, StackAI reduces manual work, speeds decision-making, and empowers teams to build trusted automation at scale.
Learn more
PvEdge
PvEdge is a state-of-the-art cloud-based pharmacovigilance software crafted to deliver comprehensive and compliant safety solutions for pharmaceuticals, medical devices, vaccines, and their combinations. It features an all-encompassing safety database that streamlines the management of pharmacovigilance intake, case processing, submissions, AI-driven analytics, and safety signal detection within a single user-friendly interface. This platform is designed to meet both current and forthcoming regulatory standards, including 21 CFR Part 11, ANNEX 11, GxP, and GDPR, thus ensuring worldwide compliance. By harnessing the power of advanced automation through AI and machine learning technologies, PvEdge significantly boosts the efficiency of drug safety database management. Notable functionalities encompass automated literature review, expedited ICSR submissions, intelligent triage processes, automated signal detection, and streamlined document automation. Additionally, the system incorporates a controlled document management feature that facilitates the creation, oversight, and dissemination of essential pharmacovigilance documentation, alongside a risk-based enterprise quality management framework aimed at establishing robust quality control processes and maintaining meticulous training records. Through these diverse capabilities, PvEdge stands out as an invaluable tool for organizations committed to upholding the highest standards in drug safety.
Learn more
biologit MLM-AI
Biologit provides an extensive range of software and services aimed at improving safety surveillance in multiple sectors. Their leading offering, biologit MLM-AI, is a comprehensive medical literature monitoring system that utilizes AI technology for both global and local applications. This user-friendly, web-based platform is validated for compliance, resulting in enhanced efficiency for both human and veterinary pharmacovigilance. Notable features encompass integrated search capabilities and customizable literature screening processes, yielding productivity improvements of up to 70% thanks to AI support. Additionally, it presents a flexible and validated SaaS framework that meets GxP standards and adheres to CFR-11 regulations, alongside a database that consolidates significant global and local literature resources while ensuring automatic article de-duplication. Beyond their software offerings, Biologit also provides expert consultancy services related to pharmacovigilance and veterinary pharmacovigilance, further strengthening their commitment to safety in various fields. Their dedication to innovation and compliance positions them as a leader in the industry.
Learn more