ScoopLabs provides an AI‑driven platform that converts scientific reports, CMC packages, and related documents into dynamic IND submissions with full traceability to source files. The system continuously monitors new study and manufacturing data, flags inconsistencies, and automatically updates affected sections to keep filings synchronized with the latest science. It delivers submission‑ready narratives formatted to regulatory standards, reducing manual drafting effort for regulatory affairs teams.
Funding
Funding not disclosed
Founders
Product
Problem
Preparing and maintaining IND (Investigational New Drug) submissions requires assembling static documents that quickly become outdated as new study data and manufacturing changes emerge. Manual drafting, cross-referencing, and consistency checks are time‑consuming, leading to delays and increased risk of regulatory errors.
Solution
ScoopLabs offers an AI‑driven platform that transforms scientific reports, CMC packages, and supporting files into dynamic IND submissions. The system ingests source documents, classifies content, and maps it to the required IND structure, then generates narrative text with traceability to each source file. As new data become available, the platform automatically detects inconsistencies, highlights affected sections, and regenerates updated text, keeping the submission synchronized with the latest science. The output is formatted to read like traditional regulatory writing, reducing manual drafting effort while ensuring continuous compliance. Users can review and edit drafts within the platform, leveraging built‑in inconsistency detection to maintain accuracy across modules.
Target Audience
Primary customers are regulatory affairs teams within pharmaceutical companies and biotech firms, as well as CROs and regulatory consultants that prepare IND submissions for multiple clients.
Features
- Automated ingestion and classification of scientific reports, CMC packages, and ancillary documents into IND modules
- Generation of submission‑ready narratives with direct traceability to original source files
- Continuous monitoring that flags conflicting values and outdated language across the entire submission
- Highlighting of impacted sections and automatic regeneration of text when new study or manufacturing data are added
- Output formatted to meet regulatory writing standards, eliminating the need for post‑generation reformatting
- Collaboration tools that streamline review cycles and maintain version control