Strategic Regulatory Partnership
We understand that a successful regulatory strategy begins at the start. We partner with you to make informed decisions that pave the clearest path to approval.
Proactive Strategy
We shape your regulatory strategy from day one, helping you navigate complex pathways and apply for critical designations that can accelerate development.
Agency Fluency
Our team has extensive hands-on experience and strong working relationships with global health authorities, including the FDA, EMA, and MHRA.
Oncology & Rare Disease Focus
We specialize in the nuances of oncology, hematology, and rare disease submissions, leveraging every available expedited program to benefit patients.
Comprehensive Regulatory Affairs Services
We provide end-to-end support for every stage of the regulatory lifecycle.
1. Strategic Planning & Agency Interaction
Regulatory Strategy Development: Shaping your complete regulatory pathway to make informed decisions from the earliest stages of development.
Health Authority Meeting Management: Full support for regulatory meetings, including preparing briefing packages and attending meetings for Pre-IND, End-of-Phase 2, Pre-NDA/BLA, and FDA Type C interactions.
Oncologic Drugs Advisory Committee (ODAC): Expert preparation and support for ODAC presentations and meetings.
2. Core Application & Submission Management
- ►New Drug Application (NDA) for small-molecules.
- ►Biologics License Application (BLA) for antibodies, cell therapies, and other biologics.
- ►Supplemental NDAs/BLAs (sNDA/sBLA) for new indications or labeling changes.
- ►Premarket Approval (PMA) for high-risk companion diagnostics.
Global Submission Capability: Coordinated submissions and reviews for major global markets, including the US (FDA), Europe (EMA), and Japan (MHLW).
3. Expedited Programs & Special Designations
- ►Accelerated Approval
- ►Priority Review
- ►Fast Track Designation
- ►Breakthrough Therapy Designation
- ►Regenerative Medicine Advanced Therapy (RMAT)
- ►Real-Time Oncology Review (RTOR) for earlier, iterative data submission.
- ►Project Orbis for concurrent international submissions and reviews.
- ►Orphan Drug Designation applications in the US and EU for rare cancers and hematologic malignancies.
- ►Rare Pediatric Disease Priority Review Voucher (PRV) strategy.
4. Lifecycle & Post-Approval Management
Post-Marketing Requirements: Management of post-marketing requirements and commitments (PMRs/PMCs), including the design and execution of confirmatory trials.
Risk Management & Safety Oversight: Development and maintenance of Risk Evaluation and Mitigation Strategies (REMS) and ongoing pharmacovigilance obligations.
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
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
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.
Pair Regulatory Execution with Fractional Leadership
Bring in dedicated CMO/CTO advisory when preparing for agency interactions and milestone submissions.
Ready to scope your regulatory engagement?
From IND strategy to post-approval lifecycle — one accountable regulatory team.