Transform Your CMC, Quality &
Regulatory Workflows with Our AI Agent
Automate writing and review of CMC, quality, and regulatory documents to accelerate drug development.
Upload your file
Excel, CSV, PDF, DOCX (Max 50MB)
Recent Documents
Built for Biopharma Excellence
Specialized AI agents trained on (ICH, JP, USP, EMA and cGMP) requirements to meet global compliance.
Document Review Assistant
Upload data and receive instant compliance checks and parameter summaries.
- Automated compliance scoring
- Parameter extraction & risk assessment
- Real-time AI agent guidance
Report Writing Assistant
Upload data and receive instant compliance checks and parameter summaries.
- Template-based generation.
- Consistent formatting with .docx export
- Regulatory-grade output
GMP & Regulatory Specialization
Purpose-built for GMP and broader regulatory requirements.
- Industry-specific training (ICH, JP, USP, EMA)
- Validation protocol support
- Full CMC, regulatory & quality compliance
Simple, Powerful Workflow
Upload Documents & Data
Drag and drop SOPs, batch records, validation protocols, or technical reports.
AI Analysis
Our specialized AI agent reviews documents against GMP and regulatory standards, extracting parameters and identifying compliance gaps.
Get Results
Receive detailed summaries, compliance scores, and ready-to-submit reports in minutes.
Enterprise-Grade Security
Your intellectual property and sensitive data remain under your complete control
No Data Storage
Documents processed in memory only. Nothing stored on our servers.
Zero Training Use
Your documents never used to train our models or shared with third parties.
Secure Processing
End-to-end encryption with strict security controls and compliance standards.
Audit Ready
Full compliance documentation and validation support for regulatory audits.
Frequently Asked Questions
- Celligent is an AIpowered assistant that helps biopharma scientists create and review GMP/quality documents. It automatically analyzes uploaded documents, produces detailed parameter summaries, and can generate compliance reports that match your templates. This reduces manual work and speeds up regulatory processes.
The system supports common GMP/quality documents such as SOPs, batch records, validation protocols and technical reports. It accepts Word and PDF files and can output a formatted .docx report.
Privacy and regulatory compliance are core to the platform. Your data remains under your control, and Celligent does not use customer documents to train its models. All processing happens under strict security controls.
Celligent is trained on biopharmaspecific data and uses rulebased validation alongside machine learning. It highlights potential noncompliance and missing sections but still allows human reviewers to make final decisions. You can refine templates and validation rules to match your organization’s need.
Offer transparent pricing tiers (e.g., free trial with limited pages, professional tier with unlimited document processing, enterprise plans).
Include details of onboarding support, training sessions and technical assistance. Provide a direct contact email/phone number and mention response times.
- Of course! Just email us at support@celligent.ai and we'll get back to you as soon as possible.