Quality Executive Partners (QxP) plays an even greater strategic role in shaping the narrative, anticipating FDA concerns, and ensuring thorough documentation, especially for advanced or outsourced manufacturing models. With changes in political administration there are few policy shifts and enforcement trends worth noting that may influence how these meetings are approached.
1. Emphasis on Advanced Manufacturing & Supply Chain Resilience
The current administration has continued to support initiatives started under previous administrations to modernize pharmaceutical manufacturing. This includes advanced manufacturing (e.g., continuous manufacturing, real-time release testing). Stress on domestic production incentives for critical drugs/therapies for chronic conditions and biologics. These areas of focus could lead to more scrutiny in pre-approval meetings for manufacturers using new technologies or non-domestic sites—consultants may be especially valuable in helping sponsors frame these discussions effectively.
2. Heightened Focus on Quality & Supply Chain Oversight
There’s an ongoing FDA push for proactive quality risk management, especially for Sterile products, complex biologics, or outsourced manufacturing. Foreign sites, where increased remote and hybrid inspections have been a thing of the most recent past have changed last week to be more frequent and unsurprisingly unannounced. These areas of focus may result in tougher pre-approval inspections and more detailed CMC inquiries during meetings—emphasizing the need for well-prepared briefing packages and clear process validation data.
3. Equity, Access, and Shortage Mitigation
There is extreme political pressure to reduce drug shortages and improve access to generics and biosimilars has led to faster review timelines for certain priority generics. Increased scrutiny on supply chain robustness and site redundancy during pre-approval discussions is in focus. And if your product falls under priority pathways (e.g., CGT, 505(b)(2), accelerated approval, biosimilars), expect closer FDA attention to your CMC readiness and greater emphasis on post-approval commitments.
4. Administrative Tone: Transparency & Data Integrity
FDA leadership continues to stress transparency, data integrity, and enforcement, especially following several high-profile manufacturing issues (e.g., contamination, mislabeling, or unreliable data). Expect pre-approval meetings to reflect this stance, with direct questions about data systems, validation status, and GMP compliance—areas where consultants can add real value in preparing responses.
In summary, we know that the core structure and utility of pre-approval manufacturing meetings are unchanged. What’s shifting is the regulatory tone and focus—more proactive, risk-based, and digitally informed. Consultants now play an even greater strategic role in shaping the narrative, anticipating FDA concerns, and ensuring thorough documentation, especially for advanced or outsourced manufacturing models.
The Role We Play
1. Strategic Planning & Meeting Justification
QxP helps determine whether a pre-approval manufacturing meeting is appropriate. We assist in crafting the rationale and objectives for requesting the meeting. We ensure the timing aligns with regulatory milestones (e.g., prior to pre-approval inspection or in response to late-cycle review questions).
2. Meeting Request Submission
QxP drafts the formal meeting request letter, ensuring it follows FDA’s expectations (per guidance like the “Formal Meetings Between the FDA and Sponsors or Applicants…”). We then define and prioritize questions to the FDA, focusing on areas such as process validation, control strategies, or facility readiness.
3. Briefing Package Preparation
QxP lead or support development of a clear, targeted briefing document, including:
Manufacturing site and process descriptions; control strategies and critical process parameters (CPPs); status of validation and readiness for inspection.
We ensure alignment with FDA’s format requirements and timelines (briefing packages are usually due 1 month before the meeting).
4. Cross-functional Coordination
We coordinate between internal CMC, regulatory, QA, and manufacturing teams to ensure consistent messaging and readiness and we help identify and mitigate potential red flags ahead of the meeting.
5. Mock Meeting and Coaching
QxP conducts mock meetings to prepare the sponsor team for FDA questions. We coach presenters and SMEs (subject matter experts) on how to communicate clearly and handle challenging questions.
6. Participation in the Meeting
We can join the FDA meeting to support the sponsor team, answer questions, or manage follow-up commitments. We ensure meeting minutes are accurate and track post-meeting commitments.
7. Post-Meeting Follow-Up
QxP will analyze FDA feedback and integrate it into the overall regulatory and manufacturing strategy and assist in preparing any additional documentation or commitment tracking required before approval.
QxP has a depth of strong regulatory and technical knowledge. We have a strong background in CMC regulatory affairs. We are recognized by the US FDA and have extensive experience with FDA meeting logistics and submission process. We are familiar with pre-approval inspection (PAI) expectations and QbD (Quality by Design) principles.
Quality Executive Partners is the essential link between technical team and regulatory authorities. We ensure that no insight is lost, and no requirement is overlooked. This results in your accelerated approvals and de-risking development of your submission. We play a pivotal role in getting to market in the most efficient way possible.
Give Us a Call.
QxP Vice President Christine Feaster is a 20+ year veteran in pharma quality assurance. Prior to joining QxP, Christine was a vice president of U.S. Pharmacopeia.
