We help life sciences companies implement and optimize enterprise IT solutions, ensuring regulatory compliance and efficiency. Our consulting services include enterprise software integration, digital transformation, AI-driven automation, and cloud adoption.

Key Offerings:
 

• ERP (SAP, Oracle, Microsoft Dynamics) Implementation
• Cloud & Digital Transformation (AWS, Azure, Google Cloud)
• LIMS, MES, and QMS System Integration
• AI & Process Automation for Compliance

Ensuring that computerized systems meet regulatory requirements is critical in life sciences. Our risk-based validation strategies ensure that your IT systems remain compliant, efficient, and audit-ready.

Key Offerings: 

• 21 CFR Part 11 & Annex 11 Compliance
• Software & Application Validation (ERP, LIMS, MES, QMS)
• Automated Validation Solutions
• Change Control & Periodic Review

Our Commissioning & Qualification (C&Q) services are rooted in industry best practices and current regulatory expectations. From early design through operational readiness, we help you achieve a seamless, compliant startup while minimizing risk and avoiding costly delays.

Key Offerings: 

• Commissioning & Startup Support (URS, FAT, SAT)
• Equipment & Facility Qualification (IQ, OQ, PQ)
• Risk-Based Approach Aligned with ASTM E2500 & GAMP 5
• Turnkey Project Support Across Labs, Manufacturing & Utilities

We modernize life sciences IT infrastructure, ensuring scalability, security, and compliance. Our digital transformation solutions integrate AI, cloud computing, and cybersecurity best practices to enhance business continuity and operational efficiency.

Key Offerings: 

✔ Cloud Migration & Cybersecurity Solutions
✔ AI-Powered Compliance Monitoring
✔ IT Infrastructure & Disaster Recovery Planning

We guide companies in meeting global regulatory requirements, from GMP/GLP training to FDA audit preparedness. Our expert consultants ensure that your business remains compliant, risk-mitigated, and ready for global market expansion.

Key Offerings: 

•  FDA, EMA & Global Audit Readiness
• CAPA & Deviation Management
• Regulatory Risk Assessments
• Regulatory Submission Support

We ensure data accuracy, security, and regulatory compliance across IT systems, aligning with global data integrity standards (ALCOA+).

Key Offerings: 

• ALCOA+ Data Integrity Framework
• Audit Trail Review & Compliance Monitoring
• Electronic Data Lifecycle Management

We leverage artificial intelligence and big data analytics to streamline regulatory compliance, risk management, and quality control.

Key Offerings: 

•  AI-Driven Risk Assessment & Predictive Analytics
• Automated Document Review & Compliance Monitoring
•  AI-Powered Quality Control Solutions