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IntuitionLabs

Custom Software Development for Pharma & Biotech

AI-powered custom software solutions that cut development costs by 60-80% while ensuring FDA compliance and accelerating innovation.

AI is Revolutionizing Pharmaceutical Software Development

The economics of custom software development have fundamentally changed. AI-assisted development now reduces costs by 60-80%, making enterprise-grade custom solutions accessible to mid-size pharmaceutical and biotech companies. What once took 12-18 months can now be delivered in 8-12 weeks, with full FDA compliance and GxP validation. Learn how AI is transforming drug development and explore our GenAI implementation tracker to see what leading pharma companies are building.

Why Custom Software Now?

AI has created a unique window of opportunity for pharmaceutical companies to build competitive advantages through custom software.
Related topics
Cost RevolutionSpeed AdvantageCompliance ReadyProcess Automation
  • 60-80% Cost Reduction: AI-assisted development dramatically reduces coding time, making custom solutions financially viable for more companies.
  • 3-5x Faster Delivery: What traditionally took 12-18 months now takes 8-12 weeks with AI-powered rapid prototyping.
  • 100% Compliance Ready: Built-in FDA, GxP, and 21 CFR Part 11 compliance from day one, not as an afterthought.
  • 90% Less Manual Work: Complex processes that were too expensive to automate are now prime candidates for AI-driven automation.
  • Competitive Window: Early adopters are seeing 3-5x productivity gains. The window to establish advantage is narrowing.
  • Regulatory Preparedness: Stay ahead of evolving FDA and EMA guidance on AI in pharmaceutical operations.
Schedule a consultation to discuss your custom software needs

Clinical Trial Management Systems

AI-powered patient recruitment, protocol optimization, real-time monitoring, and predictive analytics. Our custom solutions integrate with existing EDC systems and ensure 21 CFR Part 11 compliance. Features include intelligent patient matching, site selection optimization, risk-based monitoring, and automated protocol deviation detection.
Clinical Trial Management Systems

Laboratory Information Systems

Intelligent LIMS with automated data capture, instrument integration, and quality control. We build systems that handle sample tracking, result validation, chain of custody, and integrate seamlessly with your existing infrastructure. Learn about our approach to modern LIMS implementation.
Laboratory Information Systems

Regulatory Compliance Automation

Automated document generation, submission tracking, audit trail management, and regulatory intelligence. Our solutions handle eCTD submissions, document version control, and regulatory change tracking while ensuring GAMP 5 validation.
Regulatory Compliance Automation

Manufacturing Operations Systems

Electronic batch records, equipment IoT integration, predictive maintenance, and supply chain optimization. We create systems that ensure ERP compliance while maximizing operational efficiency.
Manufacturing Operations Systems

Core Development Capabilities

End-to-end custom software solutions across the pharmaceutical value chain.

Clinical Development

EDC/eCRF systems, patient recruitment platforms, safety databases, protocol management.

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Research & Discovery

Compound library management, assay data systems, bioinformatics pipelines, lab notebooks.

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Quality Management

Digital QMS, deviation management, CAPA tracking, automated compliance monitoring.

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Commercial Operations

HCP engagement platforms, market access tools, patient support programs, omnichannel marketing.

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Manufacturing & Supply

Batch release automation, supply chain visibility, quality event management, equipment tracking.

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Data & Analytics

Real-world evidence platforms, predictive analytics, AI/ML pipelines, regulatory intelligence.

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Our AI-Accelerated Development Process

From concept to deployment in 8-12 weeks, not 12-18 months

01

Discovery & Compliance Mapping

Analyze processes, identify automation opportunities, map regulatory requirements.

1-2 weeks

02

AI-Powered Prototyping

Create functional prototypes in days using AI tools, enabling early validation and feedback.

2-3 weeks

03

Iterative Development

Continuous development with built-in validation protocols, ensuring GxP compliance.

4-8 weeks

04

Deployment & Training

Seamless deployment with comprehensive documentation, training, and ongoing support.

1-2 weeks

Built-In Compliance & Security

Every solution is designed with regulatory compliance at its core, not as an afterthought.

FDA Compliant

Full compliance with FDA regulations including 21 CFR Part 11, Part 820, and GxP guidelines.

ISO Certified

ISO 13485, ISO 27001 compliant development processes ensuring quality and security.

HIPAA Ready

Built-in safeguards for protected health information and patient data privacy.

21 CFR Part 11 electronic signatures
Complete electronic signature compliance for all system transactions
Full audit trail
Tamper-proof logging of all system activities and changes
Role-based access control
Granular RBAC with segregation of duties
Data integrity
ALCOA+ principles built into every data transaction
Validation documentation
Automated generation of validation protocols and reports
Change control
Complete version management and change tracking
Electronic records
Secure management of all electronic records
Disaster recovery
Business continuity and data protection strategies

Success Stories

Real results from pharmaceutical and biotech companies leveraging AI-powered custom software.

Global Pharma: Clinical Trial Acceleration

Challenge

Manual patient screening taking 6+ months

Solution

AI-powered patient matching system

Results

  • • 75% reduction in screening time
  • • 2x increase in eligible patients
  • • $3M saved per trial

Biotech Startup: Lab Automation

Challenge

Error-prone manual data entry from instruments

Solution

Automated LIMS with instrument integration

Results

  • • 95% reduction in data errors
  • • 60% faster sample processing
  • • Full 21 CFR Part 11 compliance

Mid-Size Pharma: Regulatory Submission

Challenge

6-month eCTD compilation process

Solution

Automated document assembly and validation

Results

  • • 80% faster submissions
  • • Zero validation errors
  • • 5 FTEs redeployed

Modern Technology Stack

Leveraging cutting-edge AI and cloud technologies for pharmaceutical-grade solutions.

AI & ML

  • GPT-4 & Claude
  • TensorFlow & PyTorch
  • AutoML platforms
  • Computer Vision

Cloud Platforms

  • AWS Healthcare
  • Azure Life Sciences
  • Google Cloud Healthcare
  • Validated environments

Development

  • React & Next.js
  • Python & Node.js
  • Microservices
  • API-first design

Integration

  • Veeva Systems
  • Salesforce Health Cloud
  • SAP & Oracle
  • HL7 FHIR

Custom Software Development: Frequently Asked Questions

Ready to Transform Your Operations with AI-Powered Custom Software?

Join leading pharmaceutical and biotech companies leveraging AI to revolutionize their software infrastructure. Start with a free consultation and ROI assessment.

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