Regulatory representatives bring experience, clarity, and poise to FDA meetings. From preparation to direct representation, they help avoid missteps, guide discussions, and boost confidence—especially for startups and global firms.
Navigating FDA meetings can be daunting, especially for startups, small firms, or international companies unfamiliar with U.S. regulatory culture. This is where regulatory representatives – experienced regulatory affairs professionals or consultants – play a crucial role. Whether acting behind the scenes in preparation or directly representing your company in front of the FDA, these experts bring invaluable experience and poise to the process. In this section, we explore how a regulatory representative can enhance FDA meeting outcomes and fill gaps that companies might have in knowledge or experience.
Regulatory representatives (or regulatory consultants) are professionals well-versed in FDA regulations, expectations, and communication styles. They might be independent consultants or part of a consulting firm (such as a CRO with regulatory services). Many have prior FDA experience or decades of industry work interacting with the Agency. Importantly, foreign companies are required to have a U.S. Agent for FDA communications; often, a regulatory consultant serves in this capacity, acting as the liaison for official correspondence. But beyond formal roles, a regulatory rep is essentially your guide and advocate in dealing with FDA.
These representatives can participate in any FDA meeting – from pre-submission Q-Sub meetings to advisory panels – as a member of your team. They can even lead the meeting dialogue if appropriate. FDA permits sponsors to bring whomever they need to meetings (consultants, attorneys, etc.), as long as their names and roles are provided in advance.
A regulatory consultant will help prepare a winning strategy for the meeting. They know what FDA is likely to question, what level of detail to provide, and how to frame issues. For example, in a Pre-Sub meeting prep, an expert can help craft the list of questions to FDA to ensure they are clear and not inadvertently inviting unwanted issues. They can also review your briefing materials or slides to ensure they align with FDA’s perspective and guidance. Essentially, they make sure you “speak FDA’s language.” As one consulting service advertises, tapping regulatory experts with FDA communication experience gives you “peace of mind knowing that your time together will be well spent.” In practice, this might mean the consultant runs mock Q&A sessions or edits your presentation to be more FDA-friendly.
For startups or small companies with no in-house regulatory veterans, the answer is almost always: from the very beginning. Even before scheduling an FDA meeting, having a consultant help with your Q-Submission preparation or your PMA strategy can shape the need and goals for that meeting appropriately. International firms unfamiliar with U.S. norms should definitely use a U.S.-based regulatory consultant to bridge cultural and regulatory gaps.
Even larger companies use external experts for particularly high-stakes meetings (for example, a contentious advisory panel where the company brings in an outside regulatory attorney or former FDA official to help present). Essentially, whenever you feel your team might not have the specific FDA experience or might be too “close” to the product to be objective, a regulatory representative is beneficial.
Industry surveys and anecdotes abound of companies that, on their own, had lackluster FDA meetings, then with consultant help turned things around. For example, a small medtech firm might have struggled to address FDA’s questions in a Pre-Sub, receiving ambiguous feedback. The second time, they engaged a consultant who reframed their questions and data presentation – the result was a much clearer FDA response and a solid path forward.
In one scenario, a sponsor included too many people and extraneous details in a meeting, which confused the FDA. Learning from that, they let a regulatory consultant lead the next meeting, who kept the discussion focused and concise; FDA later commented the meeting was much more helpful. Another example: a company facing a skeptical advisory panel brought in a team of regulatory and clinical experts to prep and co-present – the panel’s tone shifted to more favorable because the presentation anticipated all their concerns (this was due to the reps’ experience with panel expectations). These stories underscore that regulatory experts often see what companies might miss.
It’s telling that even the FDA acknowledges the presence of knowledgeable representatives. In a guidance or public comment, FDA officials have noted that meetings tend to go smoothly when sponsors are “well-prepared and accompanied by experienced regulatory professionals.” While FDA doesn’t require it, they implicitly appreciate when a sponsor’s team is augmented by someone who understands the process – it makes the regulator’s job easier too.
A seasoned regulatory representative can be the difference between a stumbling FDA interaction and a stellar one. They bring perspective, polish, and pragmatic advice to ensure your message lands correctly with the Agency. Especially for those new to FDA processes, their guidance can prevent costly misunderstandings and keep the relationship with FDA positive. As the saying goes, “There’s no substitute for experience.” By involving a regulatory expert in your FDA meetings, you leverage a wealth of experience – often including hundreds of past FDA meetings – to bolster your case. Our firm, for instance, provides regulatory representation services with former FDA staff and veteran consultants who routinely meet with the Agency. We’ve seen first-hand how having the right person at the table can instill confidence in FDA and steer the discussion toward a successful outcome. In summary, if you have any doubt about facing FDA alone, consider bringing a knowledgeable representative to the table – it’s an investment that can pay off in approvals and accelerated timelines.
