Real submissions.
Public access.
Human-readable.

CTD Commons preserves and shares regulatory filings from biotech companies that have entered bankruptcy, recovering knowledge that would otherwise stay buried in FDA archives. We built the viewer that makes those filings readable. Together, we are making real IND submissions publicly accessible in a way they have not been before.

For many emerging biotechs, the Common Technical Document (CTD) is both critical and strangely invisible. Every company that advances a medicine eventually has to operate in this world, but many first-time teams have never written a CTD-style submission. In many cases, they have never even seen one. There are few good public examples, and the examples that do exist are often difficult to navigate as real working documents.

That matters. Regulatory knowledge is not just what is written in guidance. It is also how a team organizes evidence, explains tradeoffs, connects chemistry and manufacturing to preclinical and clinical work, responds to questions over time, and builds a submission history that regulators can actually review. Seeing real examples helps demystify the process. Reading them like a human turns that knowledge into something usable.

The CTD is the internationally accepted structure for submitting drug applications to regulatory authorities, based on the ICH M2 guideline. These dossiers contain detailed information about drug chemistry, manufacturing, preclinical studies, and clinical trial results.

This knowledge often took years and millions of dollars to generate. When a company folds and those documents disappear, other teams may repeat similar experiments, make similar investments, and reach similar dead ends. Making these materials available changes that, particularly for small biotechs who need to understand how complex regulatory submissions are actually assembled.

An Investigational New Drug application (IND) submitted in CTD format can evolve over many years and include many submissions, amendments, reports, and supporting documents. If you have ever tried to read one, you know what it takes: navigating folders and subfolders, opening and closing files across versions, trying to assemble the full picture in your head.

That is why we built the CTDCommons Viewer.