Accelerate Your Success with Corealis Pharma and the FDA Commissioner’s National Priority Voucher Program

Leverage Corealis Expertise to Unlock Fast-Tracked FDA Approval

The US FDA’s recent launch of the Commissioner’s National Priority Voucher (CNPV) Program on June 17, 2025, marks a transformative opportunity for pharmaceutical innovators. This bold initiative is designed to expedite review timelines for drug products that address urgent US national priorities: combating health crises, closing gaps in public health needs, and advancing domestic manufacturing for greater national security.

For life sciences organizations, the CNPV program is more than a regulatory development, it’s a new pathway to bring critical therapies to patients, faster than ever before. By streamlining FDA review, this program promises to ease the burden of disease globally, delivering hope to patients and empowering sponsors to make a tangible difference in healthcare outcomes.

Corealis Pharma: Your Optimal Partner for CNPV Success

The path to obtaining a CNPV voucher is defined by speed, compliance, and quality. To qualify, sponsors must submit the CMC (Chemistry, Manufacturing, and Controls) section and draft labeling at least 60 days ahead of the final application. This accelerated timeline demands flawless execution, meticulous attention to regulatory detail, and a proven ability to deliver under pressure.

At Corealis Pharma, we are uniquely equipped to help Biotech and Biopharma seize this opportunity. As a North American leader in early phase Oral Solid Dose (OSD) pharmaceutical development and manufacturing, we combine scientific excellence with a culture of agility. Our state-of-the-art facilities, experienced technical team, and unwavering commitment to quality, ensures that your CMC data package is not only complete and compliant, but also delivered on time, every time.

• Proven Track Record: Corealis has successfully supported clients through expedited regulatory pathways, earning a reputation for reliability and innovation.
• Integrated CMC Solutions: From early formulation to commercial scale-up, our end-to-end services are designed to streamline every phase of your development journey.
• Collaborative Partnership: We work as an extension of your team, tailoring our approach to your unique challenges and goals, because your success is our success.

Maximize Your CNPV Advantage with Corealis

With a limited number of CNPV vouchers available, preparation is everything. By choosing Corealis Pharma as your early phase OSD development partner, you gain more than technical expertise, you gain a strategic ally dedicated to accelerating your timelines and optimizing your chances for fast-tracked approval.

Our commitment to excellence, efficiency, and transparency ensures that your program moves forward with confidence. Together, we can help you deliver breakthrough therapies to the patients who need them most, without delay.

Ready to Accelerate?

Let’s unlock the full potential of the FDA CNPV Program together. Reach out to Corealis Pharma today to learn how our integrated solutions, regulatory acumen, and client-focused approach can position your next drug product for regulatory success and rapid market entry.

The future of expedited drug development is here. Partner with Corealis Pharma and turn opportunity into achievement, bringing hope and healing to patients, faster than ever before.

For inquiries, please contact:
Patrick Frankham, VP, Business Development
Corealis Pharma Inc.
Email: patrick.frankham@corealispharma.com
Phone: +1 (450) 973-7505
www.corealispharma.com