Pharmaceutical Regulatory Intelligence

SOP Compliance, Redefined by AI

Upload your SOPs. Receive instant AI-driven analysis against USFDA, EMA, CDSCO, GMP, and WHO — with audit-ready reports and citation-backed non-compliance findings.

Launch SOP Compliance Pro  → Explore Features
6+
Regulatory Frameworks
AI
Powered Analysis Engine
100%
Citation-Backed Reports
<60s
Full Compliance Review
Core Capabilities

Built for Regulatory Precision

Engineered for pharmaceutical compliance professionals. No noise — only signal.

📄

Document Analysis

Upload SOPs in any format. The AI parses, understands, and maps each section to relevant regulatory clauses automatically.

⚖️

Multi-Framework Review

Simultaneously checks compliance against USFDA 21 CFR, EMA, CDSCO, WHO GMP, ICH, Schedule M, and more.

🔍

Gap Detection

Pinpoints non-compliance with precision — missing clauses, incorrect language, procedural gaps — all cited to source guidelines.

📊

Audit-Ready Reports

Structured compliance reports with regulatory citations, severity levels, and corrective action recommendations.

Instant Turnaround

What once took days of manual review now completes in under 60 seconds — without compromising accuracy or depth.

🔒

Pharma-Grade Integrity

Every output is traceable, explainable, and audit-defensible. Built with the rigor pharmaceutical compliance demands.

Supported Frameworks

Global Regulatory Coverage

Aligned across the world's most critical pharmaceutical regulatory bodies.

USFDA 21 CFR
EMA Guidelines
CDSCO
WHO GMP
ICH Q7 / Q10
Schedule M
ISO 15378
EU GMP Annex
PIC/S
TGA Australia
Process

Four Steps to Compliance

From document upload to actionable compliance report — streamlined, traceable, repeatable.

Step 01

Upload Your SOP

Upload your Standard Operating Procedure — PDF or Word. The AI extracts and structures the full content automatically.

Step 02

Select Guidelines

Choose the regulatory frameworks to review against — USFDA, EMA, CDSCO, WHO, or all simultaneously.

Step 03

Receive Your Report

A structured compliance report is generated — gaps identified, citations provided, severity classified, actions recommended.

Step 04

Act & Archive

Download audit-ready documentation, implement corrections, and maintain a traceable compliance history.

Live App Demo

Watch the AI Audit in Action

Six intelligent steps — from raw SOP to a GxP-ready compliance report.

01
Document Ingestion
Upload & parse SOP
02
Framework Selection
Choose regulations
03
AI Analysis
Gemini processes SOP
04
Report Generation
Score & findings
05
Audit Trail
21 CFR Part 11 log
06
CAPA Initiation
Corrective actions
synapserxai.com/app
SOP Document Upload
Step 1 of 6
📄
Drop your SOP here
PDF, DOCX, or TXT · Max 50MB
Browse Files
Select Regulatory Frameworks
Step 2 of 6
USFDA 21 CFR
Part 11 / 211
EU GMP
Annex 11
WHO GMP
Guidelines
CDSCO
India Standards
ICH Q10
Pharma QMS
Schedule M
India GMP
3 frameworks selected · AI will cross-reference all clauses
AI Analysis in Progress
⚡ Processing
AI
▸ Chunking SOP into logical sections...
▸ Cross-referencing USFDA 21 CFR clauses...
▸ Checking EU GMP Annex 11 requirements...
▸ Scanning CDSCO compliance points...
▸ Identifying critical gaps & deviations...
▸ Categorizing findings by risk severity...
▸ Generating compliance score...
Compliance Report
Report Ready
70%
● Critical2 findings
● Major4 findings
● Minor6 findings
SectionViolationSeverity
§4.2 Audit TrailMissing automated timestampCritical
§6.1 ResponsibilitySecond checker undefinedMajor
§3.4 Access ControlRole matrix absentMajor
Audit Trail Log
21 CFR Part 11
09:14:02admin@synapserxaiFILE_UPLOAD
09:14:05admin@synapserxaiPARSE_COMPLETE
09:14:08systemFRAMEWORK_LOCKED
09:14:09gemini-proAI_ANALYSIS_START
09:14:52gemini-proAI_ANALYSIS_COMPLETE
09:14:53admin@synapserxaiREPORT_GENERATED
09:15:01admin@synapserxaiREPORT_REVIEWED
CAPA Initiation
2 Critical Gaps
● Critical CAPA-2025-001
Missing automated timestamp in audit trail (§4.2)
Corrective Action
Implement system-generated UTC timestamps for all review events. Disable manual date entry fields.
● Critical CAPA-2025-002
Second checker role undefined in procedure (§6.1)

Begin Your First Compliance Review

No setup required. Upload your SOP and receive a full regulatory analysis in under 60 seconds.

Launch SOP Compliance Pro  →