Key Deliverables
Comprehensive support tailored to your specific regulatory needs.
Preclinical Strategy
Expert guidance on preclinical study design, toxicology requirements, and IND-enabling studies to build a robust foundation for clinical development.
Clinical Development Oversight
Strategic oversight of Phase I-IV clinical trials, including protocol development, site selection guidance, and regulatory milestone management.
Program Management
End-to-end program management from IND through NDA/BLA, coordinating cross-functional teams and ensuring regulatory milestones are met.
CMC & Manufacturing Strategy
Chemistry, Manufacturing, and Controls strategy development, ensuring your manufacturing processes meet FDA requirements at every stage.
Therapeutic Area Expertise
Deep experience in orphan drugs, ophthalmology, infectious disease, and wound care with tailored regulatory strategies for each indication.
Regulatory Submissions
Comprehensive submission preparation including INDs, NDAs, BLAs, and amendments with proven first-cycle approval success.
Our Approach
A proven methodology designed to minimize risk and maximize speed to market.
Program Assessment
We evaluate your current development stage, scientific data package, and commercial objectives to identify the optimal path forward.
Strategy Development
Our team develops a comprehensive development plan aligned with FDA expectations, leveraging accelerated pathways where applicable.
Execution & Coordination
We coordinate across functions—CMC, clinical, regulatory—ensuring seamless execution and proactive risk management.
Milestone Achievement
From Pre-IND meetings through approval, we drive your program toward each critical milestone with precision and accountability.
Ready to Accelerate Your Regulatory Success?
Contact us today to discuss your specific needs and how we can support your goals.