Global Regulatory Writing & Consulting (GLOBAL)

Well, that could have gone better. How many times do we find ourselves working with a partner halfway through a project and wish that we had made a different choice? But by then, it may be too late to meaningfully course correct. When it comes to regulatory submissions, picking the right regulatory partner is critical. Make the wrong choice and you could find yourself lost in an ocean of rework, budget overruns, or worse—delays that could cost millions. It’s a bit like the story of Goldilocks and the Three Bears, except instead of porridge, we’re dealing with regulatory submission support providers. ?? The Too-Cheap Partner: At first, it seems too good to be true—low-cost services, fast turnaround times, and a promise to get you through the process smoothly. But soon, reality hits. The advice is shallow, the work is outsourced or offshored to less competent individuals, the documents are riddled with gaps and errors, and the FDA kicks back your submission with significant deficiencies. Now, you're spending double—hunting through documents to find out where things went wrong and fixing what should have been done right the first time. The “bargain” has turned into a financial and regulatory nightmare that all too often escapes direct notice from the initial decision makers. ?? The Too-Expensive Partner: On the other end of the spectrum, you find a high-end consulting firm with decades of experience or a world spanning CRO with comprehensive service offerings. These entities charge premium rates and deliver exceptional insights. Everything looks promising—until you quickly hit your budget. Suddenly, you find yourself on your own. Sound familiar? I’ve seen the same thing happen many times in my legal career—litigants left without representation right before a final hearing when their retainer ran dry. Regulatory submissions shouldn’t feel like a high-stakes trial where your advocate vanishes before the verdict. ? The Just-Right Partner: The ideal regulatory partner balances expert advice with a commitment to seeing you through the entire journey. They meet you where you’re at, provide strategic guidance, ensure high-quality documentation, and stay engaged throughout the submission process—without breaking your budget. This is the team that aligns with your goals, understands your constraints, and navigates challenges with you, every step of the way. When choosing your regulatory partner, don’t let cost alone dictate your decision. Find the one that’s just right—an expert who will guide you through the entire process, from strategy to submission, and ensure success without surprises. Have you faced a “Goldilocks” moment when choosing a regulatory partner? I would love to hear your experiences in the comments! Also be sure to check out our newest blog post about IND submissions on the Global Regulatory Writing & Consulting (GLOBAL) Perspectives Blog: https://lnkd.in/gCR4cfjP

One of our biggest strengths at GLOBAL is the quality of our team members. We are proud to have a team of world-class scientists and regulatory experts working with our clients and partners to deliver world-class results. Check out our Global teammate Jaclyn Scott, PhD - Principal, Regulatory CMC - sharing her insights into great IND writing.

Here at GLOBAL, we know that embarking on the journey toward your first clinical trial is an important milestone for any biotech company. In the U.S., before going into the clinic, a sponsor is required under 21 CFR 312 Subpart B to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA). Determining the optimal timing for IND submission can be complex and requires strategic planning. Check out our most recent blogpost on the GLOBAL Perspectives Blog where we discuss the core requirements for a successful IND submission, the strategic advantages of scheduling a pre-IND meeting, and how to prepare in a way that not only streamlines the review process but also reduces the risk of encountering a clinical hold. https://lnkd.in/dPPtCxVJ

Navigating IND Module 3 requirements? GLOBAL's CMC team specializes in delivering high-quality, compliant documentation with efficiency and precision. Whether you need support with regulatory submissions, technical writing, or expert guidance through the complexities of CMC requirements, we've got you covered. ?? Why choose GLOBAL? ? Deep expertise in IND Module 3 submissions ? A team of seasoned regulatory professionals ? Seamless, efficient support tailored to your needs Connect with us today! ?? https://lnkd.in/dD6U_q6e

Is your internal team struggling to keep up with clinical evaluation timelines and workloads under EU MDR? The Global Regulatory Writing & Consulting (GLOBAL) Medical Device Team recently concluded a campaign addressing best practices for CER Teams. We wrote several blog posts around managing resourcing, common team building mistakes, and hiring the right medical writer for your team. All of which can be found here: https://lnkd.in/guFPtTSs The team also shared some new case studies: GLOBAL EU MDR Case Study: Clinical Evaluation Update with Consulting and Project Management for a Small Start-up with New Device Technology GLOBAL PMA Case Study: Clinical Investigational Reports for Medical Devices: Supporting Compliance with a Cross-Functional Team Both can be found here: https://lnkd.in/g_5AThuv Finally, don’t miss our webinar series, where industry experts Luke Baker, PhD and Beth Meier discuss best practices for assessing and managing team workloads, how to effectively navigate challenging deadlines, and our best tips and tricks to getting the most out of your internal teams. The webinar series has been posted here: https://lnkd.in/g6EVtMjp I am so proud of all the work that this that team continues to do every day. Contact GLOBAL today to learn more about how our incredible writers and consultants can benefit your organization. https://lnkd.in/gWuC8-2q

Last week our Medical Device team met in New Orleans for 3 days of fun, teamwork, and learning! We engaged in learning and reflection sessions that dug into our ways of working, DEI, marketing and business development, and advanced certifications. We brainstormed ways to improve our operations and discussed future strategies to enhance our client relationships. And of course, we made time for team building and fun - from a swamp tour, to a jazz concert, to exploring the streets of the French Quarter! We walked away energized and ready to continue to deliver top quality to our partners and clients. Cheers to a great start to 2025!

Check out the fourth and final installment of our webinar series around Team Resourcing Management! Our Medical Device team has a lot of experience with resourcing and managing regulatory writing teams working on clinical evaluation reports. In this GLOBAL webinar, Medical Device Manager Beth Meier discusses key insights to understanding team resourcing and tips to manage these resources. Key Topics ?? Using team dynamics to manage project urgency ?? Scheduling tips to maximize efficiency and effectiveness of teams ?? Exploring resolutions to best fit your needs Check out the clip below and see the full webinar on our website: www.globalrwc.com/webinars #RegulatoryWriting #EUMDR #MedicalWriting #ProjectManagement #MedTech

At GLOBAL, we can work with clients to build a regulatory document from scratch or provide support on existing documents to bring them into alignment with regulatory requirements. Check out this Case Study covering how the GLOBAL team supported converting a clinical investigation report to the ISO 14155:2020 format with full incorporation of all TLFs and in-report hyperlinks. Book a consultation today to see how GLOBAL can support your team! https://lnkd.in/dD6U_q6e

In the 4th and final installment of our Team Building Webinar Series, Beth Meier of our Medical Device team discusses a case study outlining how teams can adapt to accommodate new and urgent projects. Save the date for March 5th and check out the previous three webinars here: www.globalrwc.com/webinars

Learn about best practices for managing CER workload under EU MDR! Our Medical Device team has a lot of experience with resourcing and managing regulatory writing teams working on clinical evaluation reports. In this GLOBAL webinar, our Medical Device Manager Luke Baker, PhD discusses key insights to understanding team resourcing and tips to manage these resources. Key Topics ??How to Divide and Conquer as a team ??Ways to make Literature Searches efficient ??How to maximize a Project Lead role Check out the clip below and see the full webinar on our website: www.globalrwc.com/webinars #RegulatoryWriting #EUMDR #MedicalWriting #ProjectManagement #MedTech