Cited to source
Answers trace to clinical data, FDA filings, and published literature
The agentic platform for life sciences
Arca connects the scientific and regulatory record into a single agentic platform for life science teams.
Capabilities
One evidence base for research and drafting
The questions a regulatory or scientific team asks and the documents it writes draw on the same evidence: literature, agency guidance, and your own submission history. Arca cites all of it the same way.
Vision
Less time on paperwork
Life sciences teams spend more time coordinating paperwork than advancing science. Arca takes on the research and first drafts.
Months of work in weeks
Research and drafting that took months, done in weeks with the audit trail intact
Drafted in-house
Your team drafts submissions and reports itself, from cited evidence
Built for workDraft submission, quality,
Draft submission, quality,
and clinical documents
Arca drafts each document from the sources your team already cites, and links every claim back to them.
01Regulatory submissions
IND, NDA/BLA, 510(k), PMA/De Novo, eCTD, Pre-Sub/Q-Sub
02Quality and CMC
CMC/Module 3, SOPs, CAPA, IQ/OQ/PQ, ISO 14971
03Clinical
Protocols, CSRs, ICFs, investigator brochures, CERs, PSUR/PBRER
510(k)
Search FDA premarket submissions to find predicate devices and substantial equivalence pathways.
MAUDE
Pull adverse event reports to surface device malfunctions, injuries, and safety signals.
ClinicalTrials.gov
Look up trial protocols, status, and results to support study and submission work.
FDA Database
Query approvals, recalls, warning letters, and registrations to check regulatory status.
PubMed
Search biomedical literature to ground claims in published clinical evidence.
80+ MORE
EMA, EUDAMED, MDCG guidance, DailyMed, AccessGUDID, eCFR, Federal Register, Global Index Medicus, and more.
SecuritySecurity and
Security and
access controls
Arca is SOC 2 Type II certified and GDPR compliant, and runs each customer in a single-tenant environment.
SOC 2 Type II
SOC 2 Type II certified, with independent audits validating our data security, availability, and confidentiality controls.
SAML and audit trails
SAML single sign-on, with activity logs of who accessed what.
GDPR and EU hosting
GDPR compliant, with a data processing agreement and EU Standard Contractual Clauses, and dedicated EU-hosted deployments for data that must stay in the EU.
Single tenant
Dedicated environments, scoped permissions, and tenant-level controls keep customer work isolated.
Team
Built by people from life sciences and AI
