In times of FDA budget cuts or staffing shortages, sponsors may face longer review timelines, reduced communication, and slower regulatory processes. Partnering with experienced regulatory consultants like Quality Executive Partners becomes even more critical during such periods. QxP provides:
1. Baseline Assessments
- Early-stage strategic planning aligned with current FDA expectations.
- Identification of potential regulatory risks and mitigation strategies.
- Gap assessments of preclinical and clinical data to preempt FDA concerns.
Benefit:
Reduces likelihood of delays due to incomplete submissions or avoidable review issues.
2. Accelerated Pathways and Regulatory Intelligence
- Up-to-date knowledge on expedited approval pathways (e.g., Fast Track, Breakthrough, Priority Review, RMAT).
- Insights into evolving FDA policies, guidance documents, and real-time response to regulatory climate shifts.
Benefit:
Sponsors can leverage appropriate pathways and respond proactively to regulatory constraints.
3. High-Quality Submission Preparation
- Expertise in compiling and QC’ing eCTD submissions.
- Understanding of how to present data clearly and concisely to regulators.
- Pre-IND, End-of-Phase, and Pre-NDA/BLA meeting preparation.
Benefit:
Minimizes review cycles and back-and-forth queries from the FDA.
4. Communication Channel Optimization
- Assistance drafting meeting requests, briefing books, and formal responses.
- Coaching for sponsor team interactions with FDA.
- Experience navigating informal communications when formal access is limited.
Benefit:
Maximizes the value of limited FDA interactions during resource-constrained times.
5. Global Regulatory Strategy Integration
- Harmonization of U.S. regulatory strategy with EMA, MHRA, and other international agencies and compendial organizations.
- Parallel submission planning to reduce time-to-market globally.
Benefit:
Diversifies regulatory risk and opens alternate market opportunities.
6. Post-Approval Planning & Lifecycle Management
- Planning for post-approval commitments, REMS, and labeling negotiations.
- Change management strategies for scale-up, tech transfer, or CMC changes.
Benefit:
Reduces regulatory friction after approval and enables smoother market expansion.
Let QxP help guide you through regulatory uncertainty—toward faster filings, approvals, and long-term success.
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.
