# DDi

> DDi (Drug Development Informatics), a Makro Group company, supplies modular regulatory, clinical and quality software to life sciences organizations worldwide. Its portfolio connects regulatory intelligence, product registrations, document operations, trial randomization and supply management, combining rule-based automation, optional AI and implementation services.

- **Founded:** 2009
- **Headquarters:** South Brunswick Township, United States
- **Founders:** Mahesh Malneedi (Co-founder; described as CEO in 2018 and CTO in a November 2025 release)
- **Products:** Visu, Vistaar, mIRT, TULA, smartDOC
- **Notable:** DDi reported CorporateLiveWire Innovation & Excellence Awards 2017 recognition for Global Excellence in Life Science Technology., TULA was featured among 'The 10 Most Trusted Risk and Compliance Solution Providers' in company-republished 2018 coverage., DDi publicly reports global enterprise and mid-market customers; these counts are self-reported.

## Products & services

- **Visu** — Modular regulatory information and process platform for registrations, submissions, labeling and related workflows.
- **Vistaar** — Regulatory intelligence, monitoring, filtered alerts and impact management with manually reviewed updates.
- **mIRT** — Clinical trial randomization and supply management; includes configurable Xpress and supply forecasting options.
- **TULA** — Clinical analytics, CRO/vendor oversight, performance monitoring and risk detection across operational data and documents.
- **smartDOC** — Regulated document and intelligent content management with collaboration, content reuse and automated formatting.
- **REGai** — Deterministic rule-based automation and optional governed agentic AI for documents, QC, publishing, strategy and projects.
- **Visu UDI** — Global unique device identification data validation, integrations, authority submissions and acknowledgment handling.
- **Visu eIFU** — Electronic instructions-for-use software and associated compliance and fulfillment services.
- **Professional services** — Configuration, integration, implementation, validation-related support, hosting and support services.

## Achievements

- DDi reported CorporateLiveWire Innovation & Excellence Awards 2017 recognition for Global Excellence in Life Science Technology.
- TULA was featured among 'The 10 Most Trusted Risk and Compliance Solution Providers' in company-republished 2018 coverage.
- DDi publicly reports global enterprise and mid-market customers; these counts are self-reported.

## Latest updates

- **2026-09** — September 30: DDi announced expanded REGai technical document operations and QC, advertising 600+ checks and 400+ formatting/publishing rules.
- **2026-02** — February 27: Visu UDI upgrade announced regulatory data validation, M2M connectivity and automated acknowledgment/error handling.
- **2025-11** — November 24 PR.com release reported selection by an unnamed UK medical device company described as a $2 billion business; customer size is not a DDi valuation or contract value.

## Links

- Website: https://www.ddismart.com/
- LinkedIn: https://www.linkedin.com/company/ddismart/
- Twitter/X: https://twitter.com/DDiSmart
- YouTube: https://www.youtube.com/@ddi7159
- Instagram: https://www.instagram.com/DDIsmart/
- Facebook: https://www.facebook.com/DDiSmart/

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Profile page: https://yespress.io/ddi
Published by YesPress — https://yespress.io
Last updated: 2026-09-30