Arca helps pharma legal, regulatory affairs, clinical operations, medical affairs, commercial review, and safety teams answer questions across FDA source material, SOPs, study agreements, claims support, pharmacovigilance obligations, and medical, legal, and regulatory (MLR) review workflows.
From FDA guidance interpretation to clinical contracting, MLR review, and safety obligations, Arca helps pharma teams investigate, review, escalate, and answer from the sources reviewers already trust.
Research FDA guidance, statutes, regulations, enforcement materials, inspection priorities, labeling policy, and internal SOPs with answers tied back to source material.
Review CTAs, CRO agreements, MSAs, SOWs, site paper, data-use terms, safety reporting provisions, and vendor terms against approved pharma playbooks.
Check claims support, fair balance, medical affairs materials, patient support programs, speaker materials, privacy terms, and cross-functional approval requirements.
Surface pharmacovigilance, safety reporting, audit, publication, patient data, de-identification, secondary use, AI data rights, and transfer obligations.
Search diligence rooms for consent rights, licensing restrictions, study commitments, labeling risks, promotional issues, milestone terms, and regulatory signals.
Track guidance, enforcement signals, labeling changes, inspection policy, safety expectations, and contract obligations back to SOPs, materials, workflows, and owners.
Arca connects regulatory affairs research, clinical contracting, MLR claims review, PV obligation analysis, SOP impact review, and cross-functional approvals in one legal AI layer.
Ask Arca questions across FDA guidance, regulations, enforcement materials, labeling policy, inspection priorities, and internal SOPs. Teams can draft memos, compare obligations, and understand issue context without open-ended search.
Upload CTAs, CRO agreements, site paper, MSAs, SOWs, data-use terms, safety reporting provisions, and commercialization vendor agreements. Arca flags deviations, explains the issue, suggests fallback language, and routes unusual positions to the right reviewer.
Ask Arca to connect promotional claims, fair balance questions, medical affairs materials, patient support programs, speaker materials, privacy terms, and approval requirements back to the reference, policy, or source language a reviewer needs.
Arca helps teams connect safety reporting commitments, pharmacovigilance terms, audit rights, publication controls, labeling updates, and SOP changes to the matters, materials, and owners that need review before a submission, audit, transaction, or launch.
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