An IND-ready package, assembled as you go.

Organize pharmacology, toxicology, and CMC evidence into a regulatory-ready narrative, and design clinical programs with the guidance and precedent already in hand.

Built for: Regulatory affairs, Clinical development, Program leads

Challenges

• Evidence arrives out of order: Tox, PK, and CMC data land on different timelines, and the IND narrative gets written in a rush at the end.
• Precedent is hard to find: Knowing how similar programs were reviewed means reading hundreds of approval packages and guidance documents.
• Trial design decisions are high-stakes: Endpoints, populations, and comparators are chosen once, and getting them wrong costs years.

What LiteFold does

• Preclinical to IND: Map your pharmacology, toxicology, and CMC data onto the IND module structure and surface the gaps early.
• Biosimilarity and comparability strategy: Draft the regulatory strategy for biosimilar and post-change programs with guidance citations built in.
• Clinical trial development: Explore endpoints, populations, and comparator choices grounded in precedent from published trials and approvals.
• Living regulatory narrative: Keep a single, versioned account of the program's evidence that updates as new data arrives.