Accelerate drug discovery, optimize clinical trials, and ensure regulatory compliance with intelligent analytics and validated systems
Pharma and biotech companies face unprecedented pressure to accelerate development timelines while maintaining the highest standards of compliance, quality, and data integrity.
Managing GxP requirements, 21 CFR Part 11 validation, and evolving EU/Irish regulations. Manual tracking is error-prone and time-consuming.
Slow patient recruitment, data collection bottlenecks, and delayed analysis. Missing opportunities to identify trends and optimize protocols in real-time.
Ensuring consistent quality across batches, facilities, and production runs. Manual inspections miss subtle variations that impact product quality.
Maintaining complete, accurate, and tamper-proof records across multiple systems. Preparing for regulatory inspections is resource-intensive and stressful.
Tracking raw materials, excipients, and finished products from source to patient. Lack of real-time visibility creates recall and counterfeit risks.
Data trapped across research teams, CROs, labs, and clinical sites. Inefficient collaboration slows discovery and development timelines.
The Problem: Paper-based or basic digital logs require constant manual oversight. High risk of documentation gaps. Difficult to demonstrate continuous compliance.
The Problem: Error-prone data entry. No real-time visibility into trial progress. Limited analysis capabilities. Version control nightmares.
The Problem: Reactive rather than predictive. Quality issues discovered after production. Costly batch failures and rework.
The Problem: Data locked in separate LIMS, ELN, and research databases. Manual data transfer between systems. No unified view across R&D pipeline.
Purpose-built, validated solutions designed specifically for pharmaceutical and life sciences organizations.
Validated system ensuring continuous GxP compliance with automated documentation and audit trails.
AI-powered platform to accelerate patient recruitment, monitor trial progress, and identify safety signals early.
ML-driven quality assurance system that predicts issues before they occur and ensures batch consistency.
Unified data platform connecting LIMS, ELN, and research systems with secure collaboration tools.
Deep understanding of GxP requirements, validation protocols, and pharmaceutical workflows. Not generic software adapted for pharma.
All solutions designed with regulatory compliance built-in from day one. Full validation documentation and audit support included.
Complete IQ/OQ/PQ protocols and validation documentation. Systems meet 21 CFR Part 11, EU Annex 11, and GAMP 5 requirements.
Clients achieve 25-35% reduction in compliance documentation time and 30-40% faster trial data analysis.
Start with one department or process. Expand across R&D, manufacturing, and quality systems as you see results.
Specialized knowledge of HPRA requirements, EU GMP guidelines, and Irish pharma industry best practices.
Combining cutting-edge technology with pharmaceutical industry expertise and regulatory compliance.
21 CFR Part 11 and EU Annex 11 compliant. GDPR adherence for patient data. SOC 2 Type II certified infrastructure. Complete audit trail capabilities.
What happens: We assess current systems, compliance status, and process bottlenecks.
Your involvement: 3-4 hours with QA, IT, and operational teams. Provide access to current SOPs and validation docs.
Deliverable: Compliance Gap Analysis with prioritized recommendations and validation roadmap.
What happens: Implement one high-impact solution with complete validation documentation (URS, FS, Risk Assessment).
Your involvement: Weekly reviews with quality and IT. SME input on requirements.
Deliverable: Validated pilot system with IQ documentation and early measurable results.
What happens: Expand across departments/sites. Complete OQ protocols and system configuration.
Your involvement: User acceptance testing. Process integration. QA review and approval.
Deliverable: Fully deployed solution with completed OQ documentation.
What happens: GxP training with documented attendance. Execute performance qualification protocols.
Your involvement: Mandatory training sessions. PQ script execution with users.
Deliverable: Training records, validated system with completed PQ documentation.
What happens: QA review and system release. Fine-tune based on production use. Address any validation findings.
Your involvement: QA approval. Monitor system performance. Report issues through validated change control.
Deliverable: Validated system in production with complete validation package and summary report.
What happens: Monthly compliance reviews. Periodic requalification. Continuous improvement within validated state.
Your involvement: Monthly 30-minute compliance review. Annual revalidation planning.
Deliverable: Ongoing support, change control management, and inspection readiness assistance.
Biologics Manufacturing & Development
Challenge: Manual batch record review consuming 40+ hours per week. Compliance documentation bottlenecks delaying production releases.
Solution: Intelligent Quality Control platform with automated batch record review and predictive deviation detection.
"The validated system transformed our quality operations. We caught potential deviations before they became problems, and regulatory inspections became routine rather than stressful events."
We'll analyze your pharmaceutical operations and show you exactly how to improve compliance, accelerate trials, and enhance quality—with no obligation.
Typical response time: Within 4 business hours
Yes. All solutions include complete validation documentation (URS, FS, Risk Assessment, IQ/OQ/PQ protocols) following GAMP 5 guidelines. Systems meet 21 CFR Part 11, EU Annex 11, and HPRA requirements. We provide full validation support and inspection readiness assistance.
Our systems incorporate ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Features include electronic signatures, comprehensive audit trails, role-based access control, and data encryption. All system changes are tracked with full traceability.
Absolutely. Our platforms are designed for complex, distributed pharmaceutical operations. We support multiple manufacturing sites, CROs, clinical trial sites, and research centers with secure data sharing, unified reporting, and site-specific configurations while maintaining centralized oversight.
Most Irish pharma/biotech companies invest €40K-€120K for initial implementation including full validation, with €2K-€8K/month for ongoing support, hosting, and compliance management. Exact pricing depends on scope, number of sites, and validation complexity. We'll provide detailed pricing in your assessment.
