Compliance, fully traceable.

BioTrace was founded by quality and regulatory veterans tired of patching together compliance from spreadsheets, paper logbooks, shared drives, and half a dozen validated tools that didn't talk to each other.

We saw the same story across biotech startups, contract manufacturers, clinical sites, and academic medical centers: every team had a binder of SOPs, a backlog of CAPAs, and an inspection looming on the calendar. What they didn't have was a single auditable record of what happened, who approved it, and why.

BioTrace is that single record. It treats every change — a deviation, a document approval, a calibration, a training assignment — as an immutable event in a cryptographic ledger. Inspectors get the trail they need. Operators get out of the spreadsheet hell. Quality gets to do quality work instead of evidence assembly.

We serve biotech, pharma, medical device, CRO, and academic teams across FDA, EMA, ISO 13485, and the broader GxP family. We're proudly partnered with ORDEX Systems and DNAChain.