Cited to source
Answers trace to research data, FDA records, and published literature
The agent platform for life sciences
Arca's agents accelerate life sciences development across biotech, pharmaceuticals, and medical devices.
Capabilities
One evidence base for research and drafting
The questions a life sciences team asks and the documents it writes draw on the same evidence: literature, agency guidance, and your own development records. 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 so teams can move development forward.
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 development documents and reports itself, from cited evidence
Built for workDraft research, quality,
Draft research, quality,
and development documents
Arca drafts each document from the sources your team already cites, and links every claim back to them.
01Regulatory submissions
Submission packages, technical documentation, agency responses
02Quality and manufacturing
SOPs, CAPA, validation plans, risk assessments, CMC documentation
03Clinical development
Study protocols, clinical reports, consent forms, safety summaries
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
