DDi (Drug Development Informatics), a global leader in Regulatory Affairs systems and automation announced today that it has been selected by a leading large medical device company with annual revenues of approximately US $2 billion. The partnership aims to modernize and unify the company’s global regulatory strategy, regulatory-intelligence operations, and assessment workflows.

This strategic engagement will enable the medical-device manufacturer to enhance global submission readiness, accelerate market access timelines, and strengthen its compliance posture across multiple regulatory markets. By leveraging DDi’s deep domain expertise and technology excellence - including its advanced Visu Regulatory Information Process Platform - the client will gain a more structured, harmonized, and insight-driven approach to navigating evolving worldwide regulatory requirements.

“We are proud to be chosen by one of the most respected medical device manufacturers in the UK,” said Mahesh Malneedi CTO of DDi. “This partnership reaffirms DDi’s position as an industry leader in applying automation, AI-driven intelligence, and end-to-end regulatory solutions that empower global organizations to stay compliant, efficient, and innovation-ready.”

As part of the engagement, DDi will support the client across three major areas:
• Regulatory Strategy Development: Building an aligned, data-driven global regulatory strategy framework that supports multi-market expansion and risk mitigation.
• Regulatory Intelligence Modernization: Harmonizing global regulatory information, monitoring updates, and delivering actionable intelligence for informed decision-making.
• Regulatory Assessments Optimization: Implementing structured workflows for impact assessments, classification reviews, and compliance evaluations using DDi’s automation-ready methodologies.

The collaboration will help the organization streamline cross-functional regulatory operations, reduce manual effort, improve visibility into changing regulations, and enhance operational predictability across its product portfolio.

Learn more: https://www.ddismart.com/news-section/ddi-selected-by-uk-based-2b-medical-device-company-for-streamlining-regulatory-strategy-intelligence-and-assessments/

About DDi
DDi, a Makro Group company, is a Life Sciences-focused software products and solutions provider. Headquartered in New Jersey, USA, with offices in the UK, India, and Singapore, we deliver smarter technology and AI-driven solutions for enterprise-level Clinical Development, Regulatory, and Safety domains. Our innovative technology products and automation solutions cater to organizations of all sizes, from global Top 1000 Life Sciences companies to emerging small and mid-sized firms.