PLATFORM
Built for the workflows regulatory affairs actually runs.
Sixteen capabilities. Grouped into five layers. All local, all snapshot-versioned, all backed by open-source models you can inspect.
Hierarchical Document Ingestion
PDF and DOCX upload with section-tree parsing, semantic labeling, and Qdrant vector indexing. Tables and lists preserved as single chunks.
Regulatory Q&A
RAG-powered chat with hybrid retrieval — dense vectors, BM25 sparse, and metadata filters by region, authority, role, product type, and device risk class.
Policy Packs
Pluggable compliance packs. Ship with EU MDR, FDA 510(k), ISO 14971, ISO 13485, ICH CTD, SmPC, and Device IFU. Custom packs supported.
Basic Gap Analysis
Section-level comparison between any two documents. Detects missing content, unclear language, inconsistencies, non-compliance, and formatting issues.
Advanced Gap Analysis
Framework-specific deterministic evaluators for MDR Annex I, ISO 14971, ISO 13485, 510(k), CTD modules, drug labels, and device IFUs.
Submission Readiness Score
Weighted readiness metric from coverage findings. Blockers automatically detected and surfaced before submission.
Submission Gates
Configurable pass / fail / conditional gates. Define what "ready to submit" means for your QMS.
Grounding Validator
Every LLM output is checked against the retrieved context. Responses citing non-existent evidence IDs are blocked at the gateway.
Evidence Explanations
Per-requirement narratives with span-level citations. Each claim is linked to a specific chunk in a specific section of a specific document.
Glass Box Copilot
Natural-language queries over snapshot data. STATUS, LIST, SUMMARY, COMPARE queries answer deterministically from the snapshot — no LLM in the loop.
Document Draft Studio
Template-based regulatory drafting. SmPC, Device IFU, CTD section drafts generated from your evidence base.
Human-in-the-Loop Review Queue
Every AI-proposed output enters a reviewer queue. Confirm, override, or request a rewrite. Nothing ships unattended.
Change Impact Analysis
Propose a change to a document and simulate the downstream impact on every affected requirement before you commit the edit.
Scenario Simulation
Add or remove evidence chunks and see how the readiness score shifts. Useful for "what's the minimum viable submission" planning.
Portfolio Analytics
Cross-product run comparison, readiness trend timelines, and compliance hotspot detection across the entire portfolio.
Program Risk Intelligence
Cross-product requirement failure clustering. Surfaces shared root causes — for example, when one template error breaks ten submissions.
Org Governance
Tenant-level configuration. Approved frameworks, access control, and per-team policy packs.
Observability (optional)
Langfuse integration for LLM trace inspection, prompt analytics, and prompt-cost tracking. Disabled by default.
How MedComplyAI compares
| Criteria | MedComplyAI | Cloud LLM SaaS | Manual Review |
|---|---|---|---|
| Data residency | |||
| Hallucination control | |||
| Audit trail granularity | |||
| Framework specificity | |||
| Time to first compliance report | |||
| Per-submission cost trajectory |
Ready to see it run on your stack?
30-minute demo. We can walk through the architecture before a single document is shared.
Book a Demo