FDA MEETING CONSULTING SERVICES
Navigate FDA Meetings with Clarity and Confidence
Facet provides expert FDA meeting consulting services to help emerging life sciences companies successfully prepare for and navigate FDA meetings. We guide you toward better FDA outcomes, turning each meeting into a strategic milestone that propels your development forward.
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TURN FDA MEETINGS INTO MILESTONES
An FDA meeting is a critical part of product development in the US. It is your opportunity to reach agreement on the science, strategy, and documentation needed to advance your product to and through FDA. A strong FDA meeting can increase asset value, provide clarity on next steps, and accelerate approvals. A weak one can result in vague guidance, missed milestones, wasted resources, and a poor opinion of your company and product at FDA. The stakes are high. This step can set the pace for your entire development journey, shaping everything from an open IND to an NDA or BLA that is approved in the first cycle.
Facet Life Sciences brings decades of hands-on experience across drugs, biologics, combination products, and medical devices to every engagement. We understand the difference between an FDA meeting that checks a box and one that secures actionable outcomes. We help you select the right FDA meeting type, prepare a sound strategy, craft requests that secure the optimal format, and create background packages that anticipate questions and address concerns directly. Our comprehensive preparation ensures every interaction with the Agency builds regulatory (and investor) confidence in your science and strategy and moves your program forward with clarity and purpose.
Facet Life Sciences works with small and mid-sized life sciences companies to approach FDA meetings with purpose and precision. With decades of regulatory experience, we help Sponsors:
IDENTIFY THE RIGHT MEETING
We advise whether an FDA meeting is necessary and, if so, which type will deliver the most value for your development stage and objectives.
FRAME THE RIGHT NARRATIVE
We shape precise questions, author compelling requests, and build background packages that present your science and strategy clearly to FDA reviewers.
PRESENT THE RIGHT EVIDENCE
We prepare attendees, keep discussions focused and productive, plus provide in-meeting support, acting as an emcee, scientific expert, or coach.
ANTICIPATE REGULATORY NEEDS
We design strategies and materials that address FDA questions before they arise, helping your FDA meeting progress smoothly and without delay.
ALIGN WITH LONG-TERM GOALS
We connect each meeting to your broader development plan, reinforcing progress from early milestones through to final approval.
FDA MEETING TYPES
INTERACT AND INTERACT LITE
Early-stage engagement for novel and complex products such as gene therapies and regenerative medicine. INTERACT meetings address novel issues before a pre-IND, while INTERACT LITE offers a streamlined option for highly specific questions with simplified requests and responses.
Q-SUBMISSIONS (PRE-SUBS)
Structured FDA feedback for medical devices and device-led combination products. Pre-Subs clarify regulatory expectations, study design, and submission strategies before filing an IDE, PMA, HDE, De Novo, 510(k), or IND for a combination product.
TYPE A MEETINGS
Urgent meetings to resolve stalled development, clinical holds, or major disputes. Type A meetings are requested when a program has been halted and requires immediate FDA input.
TYPE B MEETINGS
Milestone meetings for drugs and biologics at pivotal points in development. Type B meetings include Pre-IND, End-of-Phase 1, End-of-Phase 2, Pre-NDA and Pre-BLA meetings. They allow Sponsors to align with FDA on data adequacy, safety, and study design at each stage.
TYPE C MEETINGS
Flexible discussions on scientific or regulatory issues that fall outside of milestones or urgent contexts. Type C meetings may cover protocol amendments, nonclinical studies, manufacturing changes, or pathway questions.
TYPE D MEETINGS
Focused sessions for rapid FDA feedback on one or two narrow issues. Type D meetings often follow earlier discussions and provide clarity on complex or unresolved points.
OFFICE OF ORPHAN PRODUCTS DEVELOPMENT (OOPD) MEETINGS
Guidance for rare disease therapies and orphan drug designation. OOPD help Sponsors align on submissions, incentives, and development pathways, with both formal and informal options available.
INFORMAL INTERACTIONS
Quick exchanges with FDA outside formal meeting structures, often by email or phone. Informal interactions are useful for straightforward regulatory questions and most effective when Sponsors maintain trusted reviewer relationships.
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YOUR FDA MEETING IS ONLY AS STRONG AS YOUR PREPARATION
Understanding the FDA meeting types is only half the battle. The real difference comes from preparation and execution, and that is where Facet makes the difference.
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Navigate Complex FDA Processes with Ease
FDA meetings involve more than just showing up with data. Facet helps Sponsors cut through the complexity of FDA meeting formats, timelines, and documentation so nothing gets overlooked. We guide you step by step so your team knows exactly how to prepare and what to expect.
Translate Science into Clear FDA Communication
Strong science only delivers value if FDA understands it. Facet specializes in turning technical data into clear, compelling messages that reviewers can act on. We bridge the gap between your team’s expertise and the Agency’s expectations, ensuring your meeting with FDA is productive and focused.
Benefits of Working With Facet
MEETINGS THAT SHORTEN YOUR TIMELINE
Clients move from concept to market faster because decisive feedback is secured in the first meeting, reducing the need for costly follow-ups.
PREVENTING THE MOST EXPENSIVE MISTAKES
Poor FDA meeting preparation can lead to nonclinical and clinical trials that do not support regulatory milestones, manufacturing changes that are not properly implemented or documented, and a failure to reach important agreements with FDA. Facet ensures data, documentation, and strategy are all aligned with FDA expectations before engagement.
IMPROVED APPROVAL ODDS
Facet has a track record of success getting face-to-face meetings or teleconferences with FDA. This ensures you get the most out of your meeting with FDA.
DECADES OF PROVEN EXPERIENCE
Facet’s regulatory strategists have successfully navigated FDA formal meetings across CDER, CBER, CDRH, and OGD for more than 250 companies.
OPTIMIZE RESOURCES
We align FDA meeting plans to regulatory requirements and business goals. Acting as an extension of your team, Facet provides everything from US Agent representation to complete FDA meeting management, allowing internal resources to stay focused on science and development.
How Facet Stands Apart from the Competition
Not all partners deliver the same results. Small and mid-sized life sciences companies deserve a consulting partner who understands the high stakes of FDA meetings and the preparation required to succeed. That is why so many trust Facet Life Sciences to turn FDA meetings into milestones. Here is how we stand apart from other providers.
Facet Life Sciences
- Decades of FDA meeting expertise with a proven record of securing clear feedback and keeping development timelines on track.
- FDA meeting strategies tailored to product type, development stage, and long-term regulatory goals to secure clear FDA direction.
- Complete preparation support, including background packages, targeted questions, and coaching for confident in-meeting performance.
- Proven record of turning FDA meetings into actionable outcomes that build regulatory confidence, investor trust, and forward momentum.
Other Life Sciences Consultants
- Limited experience with FDA meetings, often leading to vague guidance and unnecessary delays in development.
- Generic approaches that fail to reflect the unique requirements of your science, program, and path to approval.
- Minimal preparation support, leaving Sponsors to manage complex meeting materials and rehearsals on their own.
- Advice focused on process rather than outcomes, resulting in unclear FDA feedback and repeated requests for additional meetings.
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