Award-Winning Solutions for BioPharma Excellence
Navigate complex regulatory environments with cutting-edge automation solutions specifically designed for pharmaceutical and biotech operations. Our specialized expertise combines deep regulatory knowledge with innovative technology implementation to deliver compliant, efficient, and scalable solutions that accelerate breakthrough discoveries while maintaining the highest standards of quality and safety.
Our Expert Services
Manufacturing Operations Technology
Optimize pharmaceutical manufacturing with intelligent automation
Integrate advanced automation and process intelligence solutions designed specifically for regulated environments, transforming manufacturing operations from reactive maintenance to predictive optimization.
Environmental Monitoring Systems Award-winning environmental monitoring solutions with dual-interface design enabling real-time operations monitoring and engineering trend analysis.
Technical Capabilities:
- Integration with DeltaV, Rockwell, Siemens control systems
- Real-time monitoring with automated alarm management
- CFR Part 11 compliant audit trails and electronic signatures
- Scalable architecture supporting facility expansion
Manufacturing Execution Systems Comprehensive MES solutions optimizing production schedules, automating batch records, and providing real-time manufacturing visibility while maintaining regulatory compliance.
Regulatory Compliance & Validation
Transform regulatory requirements into competitive advantages
Comprehensive validation strategies that build regulatory excellence directly into automated workflows, accelerating operations while ensuring data integrity.
Computer System Validation
- Strategic CSV implementation and documentation
- Risk-based validation approaches that streamline processes
- Legacy system remediation and compliance enhancement
- Validation master plan development and execution
CFR Part 11 Compliance
- Electronic records and signature system implementation
- Audit trail design and management frameworks
- Data integrity assurance and monitoring systems
- Regulatory submission preparation and support
DI/DG Audits & Assessments
- Data Integrity and Documentation Governance evaluations
- Gap analysis and remediation planning
- Regulatory readiness and audit preparation
Quality Management Systems
Build operational excellence through systematic quality management
Comprehensive quality frameworks that enhance operational efficiency while ensuring regulatory compliance, transforming quality management into competitive advantage.
Quality System Implementation:
- Quality management system design and optimization
- SOP development, training, and implementation
- CAPA system implementation and management
- Document management and control systems
Regulatory Intelligence:
- Regulatory update monitoring and impact assessment
- Compliance gap analysis and remediation planning
- Inspection readiness and audit support
Specialized Automation Solutions
Tailored approaches for unique BioPharma challenges
Biotech Startups & Emerging Companies: Accelerate your path to market with scalable, cost-effective automation solutions designed for growth. Our startup-focused approach provides regulatory pathway planning, scalable infrastructure design, and quality system implementation that grows with your success. We provide specialized support for companies developing critical antiviral, cell and gene, and mRNA therapies
Contract Manufacturing Organizations: Enable multi-client flexibility with regulatory excellence through adaptable manufacturing systems, client-specific compliance frameworks, and technology transfer support that maintains quality across diverse product portfolios.
Industry 4.0 Transformations
Comprehensive digital transformation for regulated environments
Implement smart manufacturing and automation integration that leverages artificial intelligence and machine learning to optimize pharmaceutical operations while maintaining strict regulatory compliance.
Digital Solutions:
- Smart manufacturing and automation integration
- AI-powered process optimization and analytics
- IoT implementation for enhanced monitoring
- Cloud-based solutions with regulatory compliance
- Cybersecurity frameworks for pharmaceutical operations
Why Choose Us?
Award-Winning Expertise
Andre Zeibari: Inductive Automation Firebrand Award recipient, in recognition of his innovative methodology, extensive industry experience, and masterful implementation.
Regulatory Excellence
Deep knowledge of FDA, EMA, and global pharmaceutical and biotech regulations with proven DI/DG audit specialization and extensive computer system validation implementation experience.
Technology Independence
Vendor-agnostic solutions tailored to your specific regulatory requirements and business objectives, with integration expertise across all major industrial automation platforms.
Proven Implementation Success
Successful deployments across pharmaceutical and biotech manufacturing facilities with validated systems supporting regulatory submissions and zero critical audit findings on implemented systems.