Three AI systems for pharmaceutical regulatory teams: (1) PSUR/PBRER writing automation — extracts data from safety databases, literature, and ADR registries, then generates a draft in ICH E2C(R2) format in 5–7 days instead of 6–8 weeks; (2) Clinical Study Report (CSR) generation — takes SAS output datasets and statistical analysis plans, produces formatted TFLs and ICH E3-structured sections automatically; (3) ICSR processing — extracts adverse event data from emails, PDFs, and calls, formats E2B(R3) XML for CDSCO/EMA/FDA submission. One-time fixed price, full source code, no per-document fees.
Document types
Regulatory documents we automate
How it works
PSUR automation — end to end
Pricing
Fixed-price pharma document AI
- PSUR/PBRER draft generation
- Safety DB integration (Argus/Oracle)
- Literature database connector
- Signal detection summary AI
- ICH E2C(R2) format output
- CDSCO / EMA / FDA format
- PSUR + PBRER automation
- CSR TFL generation from SAS
- ICSR E2B(R3) processing
- CTD Module 2 drafting
- Medical writer review portal
- Full source code ownership
- Audit trail for 21 CFR Part 11
- All document types
- Signal detection AI (disproportionality)
- Label surveillance automation
- Multi-product, multi-MA support
- GxP-validated deployment
- 21 CFR Part 11 compliant
- Dedicated AWS GovCloud / private cloud
FAQ
Common questions
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What is AI-powered PSUR writing automation?AI PSUR automation extracts safety data from your clinical databases, adverse event reports, and literature searches — then generates a draft PSUR in ICH E2C(R2) format. XPndAI's system reduces the time to draft a PSUR from 6–8 weeks to 5–7 days. Your medical writers review and approve; the AI handles the 70% of time spent on data extraction, table formatting, and line listing generation.
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Can AI automate clinical study report writing?AI automates the data-heavy sections of a CSR in ICH E3 format: patient disposition tables, demographics, efficacy results tables, adverse event summaries, and statistical output integration. XPndAI's CSR AI takes your SAS output datasets and SAP, then generates formatted TFLs. Narrative sections still require human medical writers, but 60–70% of CSR work — data formatting and table generation — is automated. Typical savings: 3–4 weeks per CSR.
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Is the system GxP-validated and 21 CFR Part 11 compliant?Yes. Enterprise deployments include GxP validation documentation (IQ/OQ/PQ protocols), audit trails for all document actions, electronic signature workflows compliant with 21 CFR Part 11, and role-based access control. The system can be deployed on private cloud infrastructure for companies with data residency requirements. All changes are logged with timestamp, user, and reason — meeting FDA, EMA, and CDSCO audit requirements.
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What safety databases does the system integrate with?XPndAI's pharma document AI integrates with Argus Safety, Oracle Empirica, VigiBase, MedWatch, and custom in-house pharmacovigilance databases. For literature surveillance, it connects to PubMed, Embase, and custom literature search output formats. MedDRA coding is automated with a human review queue for uncertain or low-confidence codings.
Pharma document AI — India market comparison
Pharmaceutical document automation in India is a niche where options include: XPndAI (custom AI for PSUR, CSR, ICSR — fixed price, full source code, deployed for Indian pharma and CROs); Veeva Vault RIM (global enterprise SaaS for regulatory information management — expensive, not India-specific); IQVIA (global CRO with document services — outsourced, not an owned system); OpenText (document management platform — generic, requires heavy pharma customisation); and in-house medical writing teams (high cost, slow, scalability issues). XPndAI is the only fixed-price, source-code-delivered option built specifically for Indian pharma regulatory requirements including CDSCO submissions, Schedule Y compliance, and local CRO workflows.
You are a small-to-mid Indian pharma company (annual revenue ₹100Cr–₹5,000Cr) that cannot justify Veeva's per-user SaaS pricing. Veeva Vault starts at $500–$2,000/user/month. XPndAI builds a PSUR + ICSR automation system at a one-time cost of ₹8–35 lakh with full source code — no recurring license fees.