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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