News https://www.ddismart.com DDi Thu, 06 Nov 2025 09:40:11 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.3 https://www.ddismart.com/wp-content/uploads/2024/08/cropped-DDi-512-32x32.png News https://www.ddismart.com 32 32 DDi Awarded Global 100 Business Excellence 2026 by GPMG https://www.ddismart.com/news-section/ddi-awarded-global-100-business-excellence-2026-by-gpmg/ Thu, 06 Nov 2025 09:37:57 +0000 https://www.ddismart.com/?post_type=news-section&p=11585

06 Nov 2025: DDi (Drug Development informatics), a leader in regulatory, clinical, and enterprise technology solutions, has been honored with the prestigious Global 100 – 2026 Business Excellence award by GPMG. This recognition highlights DDi’s strong commitment to innovation, quality delivery, and transformative impact across the global life sciences ecosystem.

The award acknowledges DDi’s advancements in intelligent automation, data harmonization, and AI-driven platforms that simplify regulatory and clinical workflows for pharmaceutical and medical device organizations. Products like Visu, Vistaar, mIRT, smartDOC and solutions like eIFU and Regulatory Intelligence capabilities have helped life science companies improve operational efficiency, accelerate submissions, and enhance compliance transparency.

Receiving the Global 100 distinction reinforces DDi’s position as a trusted technology partner, continuously driving smarter and more connected regulatory processes worldwide.

DDi_GPMG-Award-2026
]]>
Visu selected by a leading Medical Device Manufacturer for Global UDI Compliance https://www.ddismart.com/news-section/visu-selected-by-a-leading-medical-device-manufacturer-for-global-udi-compliance/ Thu, 06 Nov 2025 09:35:03 +0000 https://www.ddismart.com/?post_type=news-section&p=11582

06 Nov 2025: A major global medical device company has chosen DDi’s Visu platform to strengthen and streamline its Unique Device Identification (UDI) compliance processes across international markets as well as EUDAMED.

The selection comes as regulatory compliance expectations for device traceability continue to expand across regions, requiring manufacturers to maintain accurate product data, ensure timely submissions, and manage ongoing updates across multiple health authority systems.

Visu, DDi’s regulatory and quality data management and operations platform, centralizes UDI data, automates validation checks, and simplifies submissions to global databases including the FDA GUDID and EU EUDAMED.

DDi-Visu_UDI-Solutions

With this deployment, the medical device maker aims to accelerate UDI readiness, enhance product data consistency, and reduce manual effort across regulatory and quality teams. The platform’s configurable workflows, audit-ready traceability, and integration capabilities were key factors in the selection.

This collaboration highlights the increasing adoption of advanced data and automation-driven solutions to meet evolving regulatory compliance demands while ensuring patient safety and product transparency.

]]>
DDi selected by UK-Based $2B Medical Device company for streamlining Regulatory strategy, intelligence and Assessments https://www.ddismart.com/news-section/ddi-selected-by-uk-based-2b-medical-device-company-for-streamlining-regulatory-strategy-intelligence-and-assessments/ Thu, 06 Nov 2025 09:30:54 +0000 https://www.ddismart.com/?post_type=news-section&p=11578

06 Nov 2025: A leading $2 Billion UK-headquartered medical device manufacturer valued has selected DDi’s AI powered Reg Intel platform to enhance its global regulatory intelligence and compliance operations. The adoption reflects increasing industry focus on automated, real-time regulatory process management as companies navigate evolving global requirements across the U.S., EU, UK, and emerging markets

DDi’s Reg Intel platform provides continuous regulatory updates, structured intelligence, and proactive change alerts, enabling regulatory and quality teams to respond quickly and reduce manual monitoring efforts. Its built-in AI capabilities help harmonize regulatory information, streamline assessment workflows, and support faster submission readiness.

After a detailed evaluation, the company chose DDi’s Reg Intel platform for its depth of coverage, data accuracy, AI based workflows, and seamless integration with internal systems. The implementation is expected to improve compliance preparedness, accelerate market access efforts, and strengthen audit readiness.

DDi-Reg-Intel

A DDi spokesperson stated, “Global manufacturers are prioritizing digital transformation to stay ahead of regulatory changes. DDi’s Reg Intel platform enables smarter, proactive decision-making and change assessment implementations”

]]>
DDi’s Visu Regulatory Platform now with AI-Powered Project Management & Impact Assessment https://www.ddismart.com/news-section/ddis-visu-regulatory-platform-now-with-ai-powered-project-management-impact-assessment/ Fri, 27 Jun 2025 10:24:13 +0000 https://www.ddismart.com/?post_type=news-section&p=10767

DDi, a leading provider of technology solutions for the life sciences industry, has announced a major enhancement to its Visu platform, integrating advanced artificial intelligence to revolutionize project management for regulatory teams in the medical device, pharmaceutical, and biotech companies.

The newly enhanced AI-based Regulatory Project Management feature brings automation, predictive analytics, and intelligent decision support to regulatory project teams, enabling faster timelines, improved collaboration, and proactive risk identification. With the increasing complexity of product development in life sciences, these capabilities are designed to streamline project execution from early-stage planning through to commercialization.

Visu’s AI enhancements provide regulatory teams with actionable insights through real-time dashboards, regulatory forecasting, collaboration with cross-functional teams, resource optimization, and adaptive learning models. The platform is tailored to meet the specific demands of both Medical Device Project Management and Pharma & Biotech Project Management, ensuring regulatory alignment and operational transparency.

“We’re committed to empowering life sciences organizations with intelligent tools that adapt to the dynamic nature of their projects,” said Mahesh Malneedi, CTO at DDi. “By infusing AI into Visu, we’re delivering a new level of control, speed, and foresight to our clients’ project management processes.”

DDi’s Visu continues to evolve as a next-generation regulatory and automation platform, supporting end-to-end regulatory process visibility and enabling teams to stay ahead in an increasingly competitive industry landscape.

About DDi

DDi is life sciences focused software Product & Solutions Company privately owned by Makro Group. With global headquarters in New Jersey, USA and other global offices in UK, India, and Singapore, we provide smarter technology for Enterprise level, Clinical Development, Regulatory and Safety domains by providing innovative technology products and automation solutions for organizations of various sizes. Our customer base includes organizations from global Top 1000 life science companies to growing small & mid-size companies.

Reference: Issue Wire, PR Log, PR Free, PR Sync

]]>
DDi wins ‘Best Global Regulatory & Clinical Development Partner 2025’ Award by GHP https://www.ddismart.com/news-section/ddi-wins-best-global-regulatory-and-clinical-development-partner-2025-award-by-ghp/ Wed, 16 Apr 2025 09:02:10 +0000 https://www.ddismart.com/?post_type=news-section&p=10483

DDi, a global leader in regulatory and clinical development solutions for the life sciences industry, has been honored with the prestigious ‘Best Global Regulatory & Clinical Development Partner 2025’ award by Global Health & Pharma (GHP). This recognition marks a significant milestone in DDi’s commitment to driving innovation and excellence across regulatory, clinical, and technology-driven services.

Presented as part of GHP’s annual International Life Sciences Awards, this accolade celebrates DDi’s exceptional performance, client-centric approach, and continued impact on advancing healthcare solutions worldwide. The award underscores DDi’s strengths in delivering efficient, compliant, and technology-enabled services that accelerate drug development and regulatory approvals.

Speaking on the win, DDi’s CEO expressed gratitude to their dedicated teams and loyal clients, crediting this achievement to their shared vision of improving global health outcomes through smarter, faster, and more integrated development strategies.

This award not only solidifies DDi’s global reputation but also sets the stage for continued innovation and leadership in the regulatory and clinical space.

]]>