Arca Regulatory AI - 2026 Pricing, Features, Reviews & Alternatives

Arca Regulatory AI is a cloud-based, single-tenant agentic platform built for regulatory affairs, quality assurance, and clinical development teams at pharmaceutical, biotechnology, and medical device organizations. Long-horizon AI agents conduct multi-step research and produce first drafts of regulatory submissions, quality documents, and clinical documents, drawing on a unified evidence base that combines agency guidance from FDA, EMA, and ICH with published literature and the customer's own submission history. Supported submission types include IND, NDA/BLA, 510(k), PMA/De Novo, eCTD, and Pre-Sub/Q-Sub formats. Every claim in a drafted document is traced back to its cited source, keeping the full audit trail intact.

The platform connects internal and external regulatory records into a single searchable environment. Agents can query FDA premarket submissions to identify predicate devices and substantial equivalence pathways, search Complete Response Letters by full text and deficiency headings, cross-reference deviation and CAPA records against FDA enforcement history, and review supplier inspection history and warning letters. This cross-referencing capability spans internal filings, protocols, SOPs, and prior correspondence alongside external regulatory databases, covering FDA approvals, recalls, warning letters, and registrations.

Arca Regulatory AI operates in secure, single-tenant environments with dedicated EU-hosted deployments available for data residency requirements. The platform supports SAML single sign-on with activity audit logs, and holds SOC 2 Type II certification with GDPR-compliant and HIPAA-ready controls. Customer data is never used to train general-purpose AI models, and all processing occurs in secure environments with human oversight. The platform is suited to organizations across the full development lifecycle, from early-stage development through established manufacturers.