A Strategic Approach to Regulatory Success
Navigating the FDA requires more than just checking boxes; it demands a proactive, informed, and strategic partnership from day one.
Proactive Planning
We help you shape your regulatory strategy from the start, identifying the most efficient pathways and critical designations to accelerate development and review.
Agency Fluency
Our team possesses deep, "hands-on" experience and strong working relationships with global health authorities, enabling productive dialogue and efficient problem-solving.
Oncology & Rare Disease Focus
We specialize in the nuances of oncology submissions, leveraging every available expedited program to bring urgently needed therapies to patients faster.
Understanding the Regulatory Toolkit
A breakdown of the key applications, programs, and designations available to drug developers in the U.S.
1. Core Application Types
- ▶New Drug Application (NDA): The standard pathway for most small-molecule drugs.
- ▶Biologics License Application (BLA): Used for biologic products, including monoclonal antibodies, cell and gene therapies, and many modern oncology agents.
- ▶Supplemental NDA/BLA (sNDA/sBLA): Filed for new indications, formulation changes, or significant labeling updates to an already approved product.
- ▶Premarket Approval (PMA): The pathway for high-risk medical devices, critically important for the companion diagnostics used to select patients for targeted cancer therapies.
2. Expedited Programs & Designations
- ▶Accelerated Approval: Allows approval based on a surrogate endpoint that is reasonably likely to predict clinical benefit. This is very common in oncology to get drugs to patients sooner, but requires confirmatory trials post-approval.
- ▶Priority Review: FDA aims to take action on an application within 6 months (compared to 10 months under standard review). This is granted to drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment of serious conditions.
- ▶Fast Track Designation: Facilitates development and expedites the review of drugs to treat serious conditions and fill an unmet medical need. It allows for more frequent meetings and communication with the FDA.
- ▶Breakthrough Therapy Designation: An even more intensive level of FDA guidance for drugs where preliminary evidence shows substantial improvement over existing therapies on a clinically significant endpoint.
- ▶Regenerative Medicine Advanced Therapy (RMAT): A designation for cell and gene therapies that can provide the benefits of Fast Track and Breakthrough Therapy, and can also support accelerated approval.
3. Oncology-Specific Collaborative Initiatives
- ▶Real-Time Oncology Review (RTOR): An FDA Oncology Center of Excellence (OCE) program allowing for earlier, iterative submission and review of key data before the full application is submitted, significantly shortening the time to a decision.
- ▶Project Orbis: A framework coordinated by the FDA OCE that allows for concurrent submission and review of oncology products among international partners (e.g., Canada, Australia, Singapore). This is highly valuable for planning global commercial launches.
4. Incentives & Other Designations
- ▶Orphan Drug Designation: Provides incentives (e.g., tax credits, market exclusivity) for drugs and biologics for rare diseases or conditions, which includes many hematologic malignancies and rare cancers.
- ▶Rare Pediatric Disease Priority Review Voucher (PRV): A program that can award a voucher for a priority review to a sponsor who receives an approval for a qualifying rare pediatric disease product. This voucher can be sold or used on another product. (Note: Program status is subject to legislative changes).
5. Safety, Lifecycle & Post-Approval Oversight
- ▶Post-Marketing Requirements & Commitments (PMRs/PMCs): Studies and clinical trials that sponsors agree to conduct after approval to gather additional information about a product's safety, efficacy, or optimal use. Confirmatory trials are a mandatory type of PMR following an Accelerated Approval.
- ▶Risk Evaluation and Mitigation Strategies (REMS): A drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. This is common for many potent oncology agents.
Quick Notes & Practical Context
- ●Because of the high unmet need in cancer, oncology sponsors should almost always be evaluating opportunities to use expedited programs (Breakthrough, Fast Track, Accelerated Approval, RTOR) to shorten development timelines.
- ●Companion diagnostics are a critical and parallel path; their regulatory approval (typically a PMA) must be synchronized with the therapeutic's approval.
- ●Incentive programs like Orphan Drug Designation should be considered very early in development, as they can have significant financial and strategic implications.
Led by Regulatory & Technology Experts
Our team has a formidable track record of successful global filings and approvals, blending deep regulatory knowledge with technological innovation.
Dr. Ashok Srivastava
President & Chief Medical Officer
With direct experience filing 27 INDs, 9 NDAs, and 3 BLAs, Dr. Srivastava has deep, practical expertise in navigating the approval process and has led numerous successful FDA meetings, including ODAC presentations.
Elias Tharakan
Chief Executive & Technology Officer
The innovator behind a "Compliant AI" framework that integrates technology with stringent regulatory requirements (ISO, GDPR, CFR Part 11). Elias ensures our processes are efficient, auditable, and built for submission success.