Knowledge That Powers Compliance.

From regulatory strategy to quality systems and product commercialization, our experts share practical guidance to help medical device, pharmaceutical, and biotech companies accelerate compliance and reduce risk.

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From Strategy to Execution: How OneGlobal Trinity M Consulting Supports Life Sciences Organizations

At OneGlobal Trinity M Consulting, we help medical device, pharmaceutical, and biotechnology organizations bridge the gap between strategy and execution. Our approach is centered on practical, cross-functional support that helps organizations understand what needs to be accomplished, establish a realistic path forward, manage risks and dependencies, and keep critical programs moving.

Global Consulting Services

Oct 45 min read

From IND-Enabling Work to First-in-Human: What FDA’s Expedited IND Pilot Says About Integrated Drug Development

From IND-Enabling Work to First-in-Human: What FDA’s Expedited IND Pilot Says About Integrated Drug Development. In September 2026, the U.S. Food and Drug Administration launched its Expedited Investigational New Drug Pilot Program, an initiative under HHS Operation TrialBlazer designed to evaluate new approaches for accelerating first-in-human clinical trials in the United States while maintaining FDA standards for participant safety and scientific oversight.

Clinical Trials

Oct 48 min read

Women’s Health and Clinical Evidence: What EMA’s Growing Regulatory Focus Means for Medicines Development

On September 28–29, 2026, the European Medicines Agency (EMA), together with partners in the European Medicines Regulatory Network, convened a multi-stakeholder workshop dedicated to women’s health. The meeting brought together regulators, patients, healthcare professionals, academia, industry, and global partners to examine existing evidence gaps, identify research priorities, and consider opportunities to strengthen medicines development and clinical research.

Regulatory Services

Oct 47 min read

Robotic Surgery and Regulatory Strategy: What FDA’s New Draft Guidance Signals for Medical Device Developers

Robotic surgery continues to advance, bringing together sophisticated hardware, software, user interfaces, surgical instruments, and increasingly complex clinical applications. For medical device developers, this complexity creates an equally important regulatory challenge: building an evidence strategy that evolves alongside the technology.

Regulatory Services

Sep 297 min read

The Next Decade of Medical Device Innovation: Why Regulatory Science Must Evolve With Technology

The Next Decade of Medical Device Innovation: Why Regulatory Science Must Evolve With Technology. On September 25, 2026, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) and the Medical Device Innovation Consortium (MDIC) convened a public meeting titled “Regulatory Science Innovations Catalyzing Medical Device Development.”

Regulatory Services

Sep 255 min read

Lets Meet @ WHX Miami Convention on June 12, 2025

Events

Jun 11, 20251 min read

How OneGlobal Trinity M Consulting Supports Orphan Drug Development

At OneGlobal Trinity M Consulting, we partner with pharmaceutical, biotech, and medical device companies to navigate the unique regulatory, clinical, and strategic pathways required for successful orphan drug development and approval.

Regulatory Services

May 20, 20254 min read