Arca helps RA teams draft materials from prior submissions, CMC data, FDA guidance, correspondence, and approved source docs, with every claim tied back to source.
Arca connects regulatory affairs research, clinical contracting, MLR claims review, 510(k) and MAUDE device research, QSR and QMS analysis, and regulatory change impact in one legal AI layer grounded in FDA and internal records.
Research FDA guidance, regulations, 510(k)s, MAUDE, and your own documents in one place, every answer traced to source.
Identify predicates, compare cleared devices, and draft submission-ready analyses in minutes, not days.
Stay ahead of evolving FDA guidance, enforcement, recalls, and safety signals before they become risks.
Search SOPs, prior submissions, quality records, and regulatory intelligence together in one workspace.
Arca draws on authoritative FDA, global regulatory, clinical, and standards sources for pharma, drug, and medical device work — continuously updated so every answer traces back to current, primary material.
Guidance, labels, enforcement, 510(k), PMA, classification, recall, and adverse-event records.
Drug labels, FAERS adverse events, device 510(k), MAUDE events, and PMA records via the openFDA API.
Structured product labeling and SPL records from the National Library of Medicine.
Trial registrations, status, interventions, outcomes, sponsors, and study metadata.
Unique Device Identification records from the global UDI database.
Biomedical literature records from PubMed and NCBI E-utilities.
European Medicines Agency guidance, assessments, and medicine information.
UK medicines and medical-device safety, licensing, guidance, and enforcement.
International Council for Harmonisation quality, safety, and efficacy guidelines.
United States Pharmacopeia standards and USP-NF reference material.
International Medical Device Regulators Forum harmonization guidance.
Canadian drug, biologic, and medical-device regulatory materials.
Arca drafts the documents life sciences teams produce, each assembled from study data, prior filings, and approved records, with every claim traceable to source.
Arca upholds the highest rigor to comply to safety and security.
Arca is SOC 2 Type II certified, with independent audits validating our controls for data security, availability, and confidentiality.
Enterprise authentication and detailed activity logs ensure secure access control and full visibility into system usage.
Arca is GDPR compliant, with data residency, processing agreements, and controls that protect personal data across the EU.
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