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.
Learn more
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
C2P
Compliance & Risks works closely with some of the most prominent brands in the world, including Dyson, Stryker, Kodak, Lenovo and Samsung. We simplify the ESG and Product Compliance process to unlock market access.
Three key elements are part of our offering:
1. Enterprise technology solution to improve productivity and efficiency with C2P
2. The market's most comprehensive regulatory content, with 40+ topics covering over 20+ industries and 195 nations worldwide
3. A team of subject matter experts are available to answer any regulatory questions you may have
We help you to monitor and assess the relevant regulations and standards that apply to your products and business. We also help you prove ESG and product compliance in order for your business to remain on the market and grow.
We have over 20 years experience working with some of the most iconic brands in the world and have a remarkable track record of helping companies to manage compliance risks more effectively than ever.
Learn more
Compliance Gate
Generate an automated PDF report that outlines the safety requirements, labeling guidelines, certification processes, and laboratory testing regulations for a diverse array of products within the European Union and the United States. This online platform serves as a valuable resource for brands, importers, and manufacturers seeking comprehensive compliance information, the ability to schedule lab tests, and tools for creating certificates and labeling files. Engaging in third-party lab testing is frequently a necessity when importing or producing goods, not only to meet legal obligations but also to effectively showcase that a product meets safety and compliance standards. The primary goal of conducting lab tests is to assess whether the product is safe and compliant with relevant regulations. For instance, lab testing can reveal the presence of hazardous and banned chemicals, including phthalates, while also evaluating mechanical safety aspects, such as the presence of sharp edges or small detachable components. Additionally, the platform can facilitate access to expert consultations to help navigate complex regulatory landscapes.
Learn more