top of page
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.
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.
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Robotic Surgery and Regulatory Strategy: What FDA’s New Draft Guidance Signals for Medical Device Developers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.
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.”
Sep 255 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.
May 20, 20254 min read
FDA Workforce Reductions & Regulatory Delays – What It Means for You
The recent FDA layoffs mark a significant shift in the Agency’s operational landscape.
Apr 3, 20254 min read
Understanding FDA Regulatory Pathways for Medical Devices
Navigating the regulatory landscape of the U.S. Food and Drug Administration (FDA) is crucial for medical device manufacturers.
Mar 31, 20252 min read
Manufacturing Inspections for Medical Devices in the USA: FDA Requirements and Best Practices
Manufacturing Inspections for Medical Devices in the USA: FDA Requirements and Best Practices
Mar 17, 20253 min read
Best Practices for Maintaining a Quality Management System
In the highly regulated medical device industry, maintaining a Quality Management System (QMS) that complies with ISO 13485:2016 is crucial.
Mar 17, 20253 min read
The Impact of AI in Medical Devices
Artificial Intelligence (AI) is revolutionizing the medical device industry.
Mar 16, 20253 min read
The FDA’s Quality Management System Regulation (QMSR) Takes Effect February 2, 2026: What You Need to Know
The FDA’s Quality Management System Regulation (QMSR) Takes Effect February 2, 2026: What You Need to Know
Feb 10, 20252 min read
Understanding IVDR Technical Documentation Requirements for In Vitro Diagnostic Devices (IVDs)
Understanding IVDR Technical Documentation Requirements for In Vitro Diagnostic Devices (IVDs)
Nov 11, 20245 min read
Best Practices for Updating Your Medical Device File
Best Practices for Updating Your Medical Device File...
Nov 3, 20244 min read
Conducting an Effective Regulatory Strategy
Conducting an Effective Regulatory Strategy...
Oct 10, 20244 min read
Tips for Creating a Regulatory Pathway for a Medical Device to be Sold in the USA
Navigating the regulatory landscape for bringing a medical device to market in the US can be challenging but essential to product safety...
Sep 30, 20244 min read
Understanding Regulatory, Quality, and Post-Market Requirements for OTC Drug Submissions: U.S. and India
In this blog, we will outline the key requirements for OTC drug submissions in both the U.S. (FDA) and India.
Sep 24, 20244 min read
Navigating FDA Requirements for Combination Products and Post-Market Reporting
Combination products, which integrate medical devices with drugs or biologics, are subject to stringent FDA regulations.
Sep 19, 20242 min read
Navigating the Complex World of Regulatory Approval: A Step-By-Step Guide for Success
Navigating the Complex World of Regulatory Approval: A Step-By-Step Guide for Success
Sep 12, 20243 min read
Preparing for FDA Pre-Submission and 513(g) Requests
Preparing for FDA Pre-Submission and 513(g) Requests.
Sep 12, 20243 min read
The Importance of Medical Writing in Regulatory Submissions
The Importance of Medical Writing in Regulatory Submissions.
Aug 13, 20243 min read
Orphan Drug Designation (ODD): An overview and Helpful Steps to Application
Orphan Drug Designation (ODD): An overview and Helpful Steps to Application.
Aug 2, 20244 min read
bottom of page