Key Deliverables
Comprehensive support tailored to your specific regulatory needs.
Target Product Profile (TPP)
We help you define the optimal TPP to align commercial goals with regulatory feasibility, serving as a roadmap for your entire development program.
Regulatory Roadmap & Pathway
Identify the most efficient path to market (e.g., 505(b)(2), accelerated approval) with a comprehensive strategic roadmap.
Pre-IND / Pre-CTA Meetings
Expert preparation and representation at critical health authority meetings to gain alignment on your development plan.
Pediatric Study Plans (PSP/PIP)
Strategic development of pediatric plans to meet FDA and EMA requirements while minimizing burden on your development timeline.
Orphan Drug Designations
Secure special status for rare disease treatments to gain financial incentives and market exclusivity.
Our Approach
A proven methodology designed to minimize risk and maximize speed to market.
Discovery & Assessment
We begin by deeply understanding your science, your goals, and the competitive landscape to identify unique regulatory opportunities.
Strategic Formulation
We develop a bespoke regulatory strategy that balances speed, risk, and commercial value, leveraging our deep institutional knowledge.
Agency Alignment
We validate our strategy through early and effective interactions with health authorities, ensuring no surprises later in development.
Execution & Oversight
We remain your partner through execution, adapting the strategy as data emerges and regulations evolve.
Ready to Accelerate Your Regulatory Success?
Contact us today to discuss your specific needs and how we can support your goals.