DDi
Regulatory, clinical, and quality automation for pharma and medical device companies.
Overview
DDi is a technology company that develops software platforms and automation solutions for regulatory, clinical, and quality teams in the life sciences industry. The company serves pharmaceutical, biotechnology, medical device, IVD, consumer health, and chemical companies, offering products that span regulatory information management, clinical trial supply, compliance, content management, and agentic AI-driven automation. DDi reports over 50 enterprise clients and more than 140 mid-market clients, with 15 years of domain expertise in the sector.
DDi's platforms are built on a modular architecture, allowing organisations to adopt individual components or deploy the full suite depending on their digital maturity and business goals. The company positions its solutions as applicable to both large enterprises and small-to-medium businesses, with documented efficiency gains ranging from 20% to 70% and a focus on total cost of ownership.
Core Product Suite
- Regulatory Information and Automation Process Platform: A platform for managing regulatory information and automating associated processes within life sciences organisations.
- Global Regulatory Compliance and Intelligence: A solution focused on regulatory compliance monitoring and intelligence, including tools such as Visu UDI, which supports regulatory data validation and serves as a unified strategic data foundation for UDI-related requirements.
- Clinical Trial Supply Management: A system for managing the supply chain associated with clinical trials, including IRT/RTSM (Interactive Response Technology / Randomization and Trial Supply Management) functionality.
- Automation and Agentic AI Platform: A platform providing fit-for-purpose AI agents designed to handle complex business workflows and reduce manual effort beyond basic task automation.
- Governance, Risk and Compliance (GRC) Solution: A solution addressing enterprise governance, risk management, and compliance requirements.
- Intelligent Content Management: A system for managing content in a structured and intelligent manner within regulated life sciences environments.
Capabilities for Large Enterprises
- Accelerated achievement of digital milestones
- Reduction of duplication through automation and workflows
- Validation and compliance-ready deployments
- Enterprise-grade security with cloud-based infrastructure
Capabilities for Small and Mid-Sized Businesses
- Fit-for-purpose functionality tailored to smaller organisations
- Low maintenance and ownership costs
- Short implementation timelines with 24x7 support
- Flexible pay-per-use pricing models
Automation and AI Approach
- AI agents are designed to manage complex business workflows, not just routine tasks
- Agentic automation is described as a shift beyond earlier automation approaches, enabling more autonomous process handling
- Applications include regulatory publishing, UDI data validation, and clinical trial supply workflows
Notable Details
- DDi was awarded the Global 100 Business Excellence 2026 recognition by GPMG
- The company publishes insights covering topics such as IRT/RTSM vendor comparisons, eIFU URL readiness for UDI databases, and agentic automation in regulatory publishing
- Visu UDI has been upgraded to automate regulatory data validation and is positioned as a unified strategic data foundation ahead of mandatory EUDAMED requirements from 2026
- Solutions are cloud-based and designed to meet validation and compliance standards relevant to regulated industries
DDi serves life sciences companies across pharma, medical devices, IVD, consumer health, and related sectors, offering both enterprise-scale deployments and accessible solutions for growing organisations seeking to digitise and automate their regulatory, clinical, and quality operations.