GMP-Compliant Pharmaceutical Intelligence

Solve Manufacturing Problems Faster

AI-powered pharmaceutical problem solver that analyzes your manufacturing issues and generates compliant, actionable solutions with regulatory citations

How It Works

Simple 3-step process to go from problem to solution in minutes

Upload & Describe

Describe your manufacturing problem and upload relevant documents

• Upload batch records (PDF)
• Upload process data (Excel)
• Upload test results (PDF/Word)
• Add photos or charts (Images)

The system automatically extracts critical parameters, specifications, and deviations from your files.

Intelligent Analysis

Advanced AI investigation with regulatory compliance

• Systematic root cause identification
• Multi-factor analysis
• Evidence-based conclusions
• Confidence scoring

Our proprietary AI engine analyzes your data from multiple perspectives to ensure accurate root cause identification with quantified confidence levels.

CAPA Generation

Actionable recommendations with regulatory citations

• Corrective actions with timelines
• Preventive actions with owners
• Regulatory requirements cited
• Acceptance criteria defined

All CAPAs include implementation steps and verification methods aligned with 21 CFR 211 and ICH guidelines.

Why Choose Pharma Solver?

Built for pharmaceutical quality and compliance professionals

Regulatory Compliance

Every recommendation is backed by authoritative regulatory sources

FDA Regulations: 21 CFR Part 210/211, guidance documents

ICH Guidelines: Q1-Q14 (Quality), Q5C (Stability)

International: EMA, MHRA, WHO, Ph.Eur., USP

Manufacturing: GMP compliance, validation, data integrity (ALCOA+)

Professional Reports

Export investigation-ready PDF reports with one click

Complete Analysis: Comprehensive investigation with systematic methodology

CAPA Documentation: Implementation steps, timelines, and owners

Citations Included: Full regulatory references for audit trail

Formatted Reports: Professional layout ready for QMS submission

Expert AI Assistant

Ask questions and get regulatory-compliant answers instantly

Manufacturing Questions: Process parameters, equipment, validation

Quality Investigations: OOS/OOT, deviations, stability failures

Regulatory Queries: Compliance requirements, inspection readiness

Session History: All conversations saved for future reference

Intelligent File Analysis

Upload any manufacturing document and get insights automatically

Batch Records: Auto-extract parameters, specs, deviations

Process Data: Parse Excel/CSV files for critical values

Test Results: Extract tables, images, and OCR text from PDFs

Multi-Format: PDF, Word, Excel, CSV, Images all supported

Common Use Cases

Solve real manufacturing problems with confidence

Stability Failures

Analyze impurity growth, assay failures, or dissolution changes during stability testing. Get root causes with ICH Q1 compliance.

OOS/OOT Investigations

Investigate out-of-specification results with 21 CFR 211.192 compliant documentation and actionable CAPAs.

Process Deviations

Root cause analysis for manufacturing deviations with GMP-compliant corrective and preventive actions.

Equipment Failures

Analyze equipment malfunctions, calibration issues, or performance problems with preventive maintenance recommendations.

Ready to solve pharmaceutical problems faster?

Join quality professionals using AI to accelerate investigations and ensure compliance