A regulatory roadmap for drugs is a comprehensive plan that integrates CMC, nonclinical, clinical, and quantitative disciplines into a single story. It defines how data will be generated, how it will be presented, and how each piece will support the label you want to achieve. Bringing a new therapy to market is rarely linear. Even with solid science, programs can stall when FDA expectations surface later than anticipated or shift midstream. Many teams have faced the frustration of uncovering evidence gaps or narrative misalignment only when approaching IND, NDA, or BLA review, after key decisions are already locked in. Early regulatory insight helps reduce these late surprises.
HIC builds drug regulatory roadmaps through direct collaboration between experienced drug developers and former FDA leaders, not automated templates. Our teams work to understand your molecule, target indications, competitive landscape, and capital needs, then map out the critical decisions from preclinical development through pivotal trials and marketing applications. The roadmap sequences nonclinical studies, CMC development, dose finding and proof of concept, registrational strategy, key regulatory interactions, and opportunities for expedited programs or appropriate use of real-world evidence. The result is a plan that reduces uncertainty, supports capital raising, and gives your team and investors a clear view of how the drug can reach approval.
Roadmaps that de-risk regulatory milestones
- We draw on experts who have guided multiple INDs, NDAs, and BLAs through review, applying practical insight into how regulatory decisions are made
- Our team of experts clarify evidence expectations at each stage, from first-in-human through Phase 3 and submission, so studies build toward a coherent benefit-risk story
- We connect CMC, nonclinical, clinical, and safety planning into one integrated roadmap, avoiding gaps or contradictions that can slow FDA review
- Our strategies align regulatory milestones with business and financing objectives, giving sponsors a plan that supports both development and capital raising
