Ritivel

The FDA approval process is infamous for taking years and costing billions—but the real bottleneck isn't science, it's paperwork. Clinical study reports, CTDs, INDs, CSRs—the amount of regulatory documentation required to get a drug or device approved is astronomical, and most of it is still being written by hand by overworked regulatory teams pulling late nights. Ritivel is here to change that.

Ritivel is an AI-native regulatory platform built specifically for pharma, biotech, medtech, and CROs who are tired of spending weeks drafting documents that should take minutes. Their platform handles the entire lifecycle—Clinical Study Reports go from Protocol plus SAP to complete CSR in minutes with word-level traceability. CTD automation pulls from PubMed, auto-drafts Module 2 summaries with cross-references. And their regulatory search instantly answers questions from FDA and ICH guidelines. The accuracy is built for medical language—not generic AI—meaning fewer factual errors, fewer reviewer comments, and higher confidence when you're submitting documents that decide whether a drug gets approved.

Here's what makes them different: consistency and traceability. Regulatory reviewers expect the same input to produce the same output every time, and Ritivel delivers that. Every word, number, and claim can be traced back to its source document at word-level granularity—so when QA or auditors ask "Where did this come from?", you can answer immediately instead of digging through files. And for companies worried about data security? No cloud storage. Fully local deployment. Your documents stay inside your infrastructure. They just launched on YC and they're already being used by regulatory teams who are done with manual drafting and last-minute rewrites. If you're in life sciences and still doing submissions the old way, you're losing time and money.