The AI kit for Regulatory Affairs Specialists

Researches requirements and summarizes compliance duties, for example turning a new agency guidance into a plain-language obligations list.

Tracks a rule change and compares it to your policy, for example flagging the three clauses your SOP must update.

Formats, compiles, and version-controls submission documents, for example packaging a module with correct headings and a change log.

Drafts and reviews regulatory correspondence and reports, for example a response letter to an agency question about your filing.

Like "Break Down Regulatory Compliance Requirements"

Like "Design Document Tracking System for Regulatory Submissions"

Like "Analyze Compliance Data"

Like "Regulatory Risk Identification"

Every registration is renewed before expiry with the file complete.

Every affected product and market carries the approved label change before release.

Each supplier change is assessed and any needed notification is identified in time.

No sunset date arrives without an up-to-date briefing and a known reauthorization status

Lets your AI look up FDA device risk, 510(k) evidence, reimbursement paths, and NHTSA vehicle safety data.

Let your AI search your Box files, answer questions about them, and pull out details for you.

Let your AI edit Word, PowerPoint and Excel files, with changes you can review before saving.

Lets your AI search the web, news, and images through Microsoft Bing while you chat.

Cleo Labs scans your website, identifies product categories and maps applicable regulations, labeling, materials and certifications across 106 countries-deliver

Doclime lets you quickly find answers within your documents. Upload files and ask questions to receive instant, accurate responses with citations, saving time a

ChatPDF lets you interact with documents in various formats, quickly extracting answers from cited sources. Select specific tables or text, ask targeted questio

Lexaclaw runs locally to find your corporate documents, extract compliance obligations, and centralize deadlines into a step-by-step system. Open-source, privat

Build a standing update feed where publication status and jurisdiction stay visible beside every regulatory change you track.

Build a review workspace that cuts manual reading while keeping every finding tied to its source document.

Build a research workspace that shortens review time and keeps each conclusion linked to the source it came from.

Build a binder that traces operational claims in your policy submissions back to the evidence supporting them.

Assesses compliance gaps and prepares audit evidence for regulatory frameworks.

Manages regulatory strategy and submissions for HealthTech and MedTech devices.

Query openFDA for drug, device, adverse event, recall, and regulatory data.

Provides FDA regulatory pathway, QSR compliance, HIPAA, and cybersecurity guidance for medical device companies.