Agentic Document Management for Regulatory Excellence

GIP's AI agents autonomously manage your regulatory documents, draft SOPs, create quality records, and suggest CAPAs. Free your regulatory and quality teams to focus on strategic compliance initiatives instead of manual document work.

Regulatory & Quality Teams Are Overwhelmed by Manual Work

Regulatory and quality personnel spend most of their time maintaining documents instead of driving strategic compliance initiatives and quality improvements

⚠️

Document Maintenance Overload

Regulatory and quality personnel spend 70% of their time on document maintenance versus strategic compliance and quality improvement work. Manual updates create bottlenecks and reduce team effectiveness.

Regulatory changes occur every 7 minutes globally
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Manual SOP Management

Manual SOP updates create compliance gaps and audit risks. Teams struggle to keep procedures current with evolving regulatory requirements.

Average SOP update cycle: 6-12 months

Quality Record Delays

Quality record drafting delays product releases and increases costs. Manual documentation processes slow down time-to-market and create compliance risks.

Manual quality records take 3-5x longer to complete

AI Agents That Work Like Your Best Regulatory & Quality Specialists

GIP's intelligent agents continuously manage your regulatory and quality workload, automatically updating documents and drafting compliance materials so your teams can focus on strategic initiatives and continuous improvement

Autonomous Regulatory Workflow

1

Monitor

AI agents continuously track regulatory changes across global agencies, identifying updates that impact your specific documents and processes

2

Analyze

Smart analysis compares regulatory changes against your SOPs, quality records, and procedures to identify specific compliance gaps and opportunities

3

Act

Autonomous agents draft document updates, create quality records, and suggest CAPAs with proper citations, routing everything through your approval workflow

Latest Regulatory Updates

Live
FDA Guidance Update
CMC Requirements - 2 hours ago
3 documents impacted
EMA Harmonization
Quality Standards - 6 hours ago
1 document requires review
PMDA Guidelines
Clinical Data - 1 day ago
No action required

Comprehensive Regulatory Automation

Complete AI-powered workflow for regulatory and quality document management with compliance automation

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SOP ManagementAvailable Now

Automatic SOP updates when regulations change, ensuring your procedures stay current with evolving compliance requirements

  • • Automated regulatory impact analysis
  • • Draft SOP updates with change justification
  • • Approval workflow integration
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Quality RecordsComing Soon

AI-drafted quality documentation with compliance citations, reducing manual effort and accelerating product releases

  • • Automated batch record generation
  • • Quality control documentation
  • • Regulatory citation integration

CAPA IntelligenceComing Soon

Suggested corrective and preventive actions from trend analysis, helping identify compliance risks before they become issues

  • • Trend analysis across quality events
  • • AI-suggested corrective actions
  • • Risk assessment and prioritization

Seamlessly Integrates with Your Existing Systems

GIP works within your current workflow, enhancing rather than replacing your established regulatory processes

PI

PI Historian

Process data integration for quality records

TW

TrackWise

CAPA workflow integration and management

V

Veeva

Regulatory document management sync

BMR

BMRAM

Equipment status integration for validation and readiness

Plus seamless API integration with your existing regulatory ecosystem

21 CFR Part 11 CompliantGxP ValidatedSOC 2 Certified

Measurable Impact on Regulatory Operations

See the quantifiable benefits of automating your regulatory document workflow

70%
Time Reduction
in document maintenance work
95%
Faster Implementation
of regulatory changes
80%
Compliance Improvement
in audit preparedness
60%
Quality Record Speed
reduction in creation time

Transform your regulatory operations from reactive to proactive

Designed for Regulatory & Quality Teams Who Want to Focus on Strategy

Perfect for pharmaceutical companies whose regulatory and quality teams are overwhelmed by manual document work and need intelligent automation to focus on strategic compliance initiatives and continuous improvement programs

Why Mid-Market Companies Choose Us

Affordable Alternative to Cortellis

Get 80% of enterprise functionality at 30% of the cost

Fast Implementation

Up and running in weeks, not months

Modern User Experience

Intuitive interface your team will actually want to use

Specialized for Biologics

Deep understanding of complex regulatory pathways

Market Opportunity

$14B+
Market size by 2030
46.1%
Medium-sized companies market share
70%
Time reduction potential

Frequently Asked Questions

Common questions about our regulatory intelligence platform

See How GIP Transforms Regulatory Work

Schedule a personalized demo to see GIP's AI agents managing your regulatory and quality workflows while automating document updates