Grounding without gaps
Every answer traces to source: clinical data, FDA filings, the published record
The agentic platform for life sciences
Arca connects the scientific and regulatory record into a single agentic platform for life science teams.
Capabilities
From research to regulatory, faster
Every question a regulatory or scientific team asks - and every document that follows from it - draws on the same underlying evidence. Literature, agency guidance, and your own submission history, held to one standard of traceability
Vision
Science, unblocked
Life sciences teams spend more time coordinating paperwork than advancing science. Arca gives that time back.
Regulatory work, compressed
Months of research and drafting, done in weeks, without cutting the audit trail
Progress and quality accelerated
Submissions and reports drafted in-house, grounded in evidence
Built for workCreate documents life sciences
Create documents life sciences
teams need, with speed and trust
Arca empowers teams to focus on the things that matter by producing artifacts grounded in the sources life sciences teams already trust.
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
510K
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
DailyMed, AccessGUDID, eCFR, Federal Register, Regulations.gov, GovInfo, U.S. Code, Global Index Medicus, and more.
SecurityEnterprise-grade security
Enterprise-grade security
and controls
Arca upholds the highest rigor to comply to safety and security.
SOC 2 Type II
SOC 2 Type II certified, with independent audits validating our data security, availability, and confidentiality controls.
SAML / Audit Trails
Enterprise authentication and activity logs deliver secure access control and full system visibility.
GDPR Compliant
GDPR compliant with data residency, processing agreements, and controls to protect EU personal data
Single Tenant
Dedicated environments, scoped permissions, and tenant-level controls keep customer work isolated.
Team
Built by leaders in life sciences and AI
