FDARx is a digital submission system — built on FDA eSTAR — that streamlines how teams assemble, manage, and file regulatory applications with the FDA. One place to build the submission, from first qualification to final filing.
Assemble every document, form, and attachment for an FDA submission in one workspace — organized, versioned, and ready to file.
Built on FDA eSTAR — the agency's structured electronic submission template — so filings arrive in the exact format reviewers expect.
Whether the device needs BDD, 510(k), De Novo, or PMA, FDARx maps the submission to the right FDA pathway from the start.
New cancer technology stalls at two gaps: regulatory and reimbursement. FDARx closes the first — turning the FDA submission from a paperwork bottleneck into a guided, structured build, connected to validation at the apex cancer centers and the path to coverage.
Pharmaceutical companies, medical-device manufacturers, and regulated teams bringing new cancer technology to market — anyone who needs to assemble and file FDA submissions without losing weeks to formatting and assembly.
Open the platform and start assembling your regulatory filing — or talk to us about the full commercialization pathway.