Custom AI platform for pharma regulatory document authoring — PSUR/PBRER, CTD/eCTD dossier, Clinical Study Reports (CSR), DSUR, and Investigator Brochure (IB) — 60–70% faster than manual authoring teams.
Every high-effort regulatory writing document — built on your internal templates, company style guide, and historical submissions.
AI-assisted Periodic Safety Update Report (PSUR) and Periodic Benefit-Risk Evaluation Report (PBRER) generation — per ICH E2C(R2) guidelines. Pulls from ICSR database, literature sources, and safety summary tables. Reduces 6-week effort to 10–12 days.
Module 2 (Quality/Non-Clinical/Clinical summaries and overviews) auto-generated from source study reports. Module 5 clinical study reports indexed and cross-referenced. eCTD XML backbone generation for CDSCO, EMA, FDA, and PMDA submissions.
ICH E3-compliant CSR drafting — synopsis, listing generation, statistical analysis cross-referencing, and appendix population from SAS/R outputs and TLF packages. Integrates with clinical data repositories.
Purpose-built AI for the PSUR narrative sections — benefit-risk section, signal evaluation, and conclusion. Trained on ICH E2C guidance and your company's approved PSUR language. Replaces the most time-consuming manual writing steps.
IB version update automation — flags new preclinical/clinical findings, updates safety sections, and tracks version history. Reduces IB update cycle from 3 weeks to 4–5 days.
Automated PubMed / Embase monitoring for your compound, extraction of relevant safety signals, and integration into PSUR Individual Case Safety Report (ICSR) line listings. No more manual literature scanning.
AI ingests your ICSR database export, previous PSUR/PBRER, safety summary tables, and literature list. Formats: CIOMS, MedDRA-coded Excel, Argus/ARISg exports, IDMP-structured XML.
Each PSUR section is auto-drafted in your company template: exposure estimates, ICSR line listings, cumulative summary tabulation, signal evaluation, benefit-risk assessment. ICH E2C(R2) section headings maintained.
Output is a Word (.docx) file with AI-generated text in Track Changes — your medical writer reviews, accepts, or edits. No black box — every AI-written sentence is visible and editable.
Auto-checks: MedDRA term consistency, cross-reference accuracy between sections, numeric consistency (line listing counts vs. cumulative tables), and regulatory template compliance. Reduces QC rounds from 3–4 to 1.
Approved document exported as eCTD-ready PDF with metadata, version tracking, and submission audit log. Integrates with Veeva Vault, Documentum, or SharePoint for final publishing.
For pharma R&D and regulatory affairs teams evaluating "pharma R&D document AI solution" or "PSUR AI writing software".
| Vendor | Type | PSUR/PBRER | CTD/eCTD | Custom Templates | India Pricing |
|---|---|---|---|---|---|
| XPndAI | Custom Dev | ✓ ICH E2C(R2) | ✓ Module 2–5 | ✓ Your templates | ₹25L–₹2Cr+ |
| Veeva Vault RIM | Enterprise SaaS | ⚡ Workflow only | ✓ eCTD publishing | ⚡ Limited | $150K–$500K/yr |
| RWS AMPLEXOR | Regulatory Services + SaaS | ✓ Full PSUR service | ✓ CTD assembly | ⚡ Service-based | Project-based (high) |
| Certara | Drug Dev Platform | ⚡ Safety modules | ✓ Clinical data | ✗ Limited | $100K+/yr |
| IDBS (Dotmatics) | Bioscience Platform | ✗ R&D data only | ⚡ Partial | ⚡ Config only | $80K+/yr |
| Instem | Safety/Tox Platform | ⚡ Safety data | ⚡ Module 4 | ✗ No | $60K+/yr |
XPndAI builds a custom pharma R&D document AI on your own company templates, regulatory history, and submission language — not a generic platform. Ideal for Indian generic pharma, CDMO, and CRO teams that need PSUR authoring automation without Veeva-level licensing costs. CDSCO, EMA, and FDA submission formats all supported.
No per-document SaaS fee. One-time build cost, run on your own servers or private cloud.
Share a sample PSUR or CTD section (redacted). We'll demonstrate the AI draft within 5 business days.