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Blog
Stay informed and ahead of the curve with Trinity M Consulting's expert perspectives and industry knowledge.
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 204 min read
Partnering with OneGlobal Trinity M Consulting: Built on Values, Driven by Results
Partnering with OneGlobal Trinity M Consulting: Built on Values, Driven by Results
Apr 212 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 34 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 312 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 173 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 173 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 102 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
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
5 Tips for Quality Checks in Maintaining an Effective Quality Management System (QMS)
5 Tips for Quality Checks in Maintaining an Effective Quality Management System (QMS)
Sep 6, 20243 min read
Navigating Market Entry in the USA: Essential Regulatory Strategies and How OneGlobal Trinity M Consulting Can Help
Navigating Market Entry in the USA: Essential Regulatory Strategies and How OneGlobal Trinity M Consulting Can Help
Sep 3, 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
Explore OneGlobal Trinity M Consulting Quality Services
Explore OneGlobal Trinity M Consulting Quality Services.
Jul 29, 20242 min read
Navigating the Transition to QMSR with OneGlobal Trinity M Consulting
Navigating the Transition to QMSR with OneGlobal Trinity M Consulting.
Jul 27, 20243 min read
The FDA’s Final Rule on Laboratory Developed Tests (LDTs): What it Means for Clinical Laboratories
The FDA’s Final Rule on Laboratory Developed Tests (LDTs): What It Means for Clinical Laboratories
Jul 8, 20242 min read
Finding the Right Consulting Company: Your Path to Success with OneGlobal Trinity M Consulting
Finding the Right Consulting Company: Your Path to Success with OneGlobal Trinity M Consulting.
Jul 8, 20243 min read
Upcoming Events
- Feb 18 - Feb 20, 2025Feb 18 - Feb 20, 2025Dallas, 650 S Griffin St, Dallas, TX 75202, USAWe’re thrilled to announce that OneGlobal Trinity M Consulting will be attending the Medtrade Event at the Kay Bailey Hutchison Convention Center in Dallas, TX! 🗓️ Expo: February 19-20, 2025 🗓️ Conference: February 18-20, 2025 Join us as we connect with industry leaders, explore the latest innov
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