Smarter solutions, trusted consulting, and safer outcomes.

Established in January 2025 , Atzek Solutions emerged from years of collaboration across the pharmaceutical , life sciences , and technology sectors. We are a fast-growing product development and consulting organization offering comprehensive services in Pharmacovigilance (PV) , IT Compliance (CSV) , Clinical Operations , Patient Monitoring , Medical Affairs , Drug Safety , Data Analytics , Signal Detection , and Quality Management & Auditing .

Our expertise also extends to ERP systems for the manufacturing industry — delivering enterprise-grade IT solutions that optimize operations, ensure regulatory compliance, and support data-driven decisions . We provide critical operational support including periodic system reviews , backup and restoration , disaster recovery planning , system decommissioning , data archival , and retirement —ensuring business continuity and compliance .

With a global team of 40+ seasoned professionals averaging over a decade of experience, Atzek Solutions brings deep cross-functional knowledge and scalable delivery models to every engagement. We're committed to delivering high-quality , compliant solutions that support the full product lifecycle —prioritizing regulatory excellence and patient safety .

End-to-end services across life sciences and IT.

ERP and compliance solutions for manufacturers.

Experienced global team with scalable delivery.

Smart Healthcare Solutions use AI, ML, and automation to transform healthcare and life sciences. These solutions improve efficiency , compliance , and patient safety through intelligent, adaptive systems.

🔍 AI-Enabled Capabilities

• Clinical Operations: Predictive analytics for trial design, site selection, and patient enrollment.
• Medical Affairs: NLP-based automation for content review and insights.
• Drug Safety & Pharmacovigilance: Intelligent workflows for case intake, triage, and validation.
• Signal Detection: AI-driven algorithms for early signal identification.
• Regulatory Reporting: Automated generation of ICSR, PSUR, and PADER reports.
• Patient Monitoring: Real-time, IoT-based remote monitoring and predictive alerts.
• IT Compliance (CSV): Risk-based validation and automated testing for streamlined compliance.

✅ Key Benefits

• Accelerated decision-making
• Improved patient safety and outcomes
• Reduced operational costs and manual errors
• Enhanced regulatory compliance
• Regulatory-compliant ready solutions
• Scalable, future-ready digital infrastructure

Atzek Solutions delivers end-to-end Pharmacovigilance (PV) consulting and validation services designed to ensure compliance, operational efficiency, and regulatory readiness throughout the drug safety lifecycle.

Our services align with global standards such as ICH E2E , GVP , EMA , FDA , and MHRA , integrating validation processes to support audit-ready pharmacovigilance systems.

🔍 Key Service Areas:

• PV System Consulting: Full lifecycle setup including SOPs and governance.
• IT Operational Support: Comprehensive IT process management including system monitoring, validation, backup, disaster recovery, and compliance assurance across Drug Safety, Patient Monitoring Systems, Medical Affairs, and Clinical Operations platforms..
• Aggregate Reporting: PSURs, DSURs, PADERs, and RMPs using compliant workflows.
• Signal Detection: AI-powered tools for early safety signal identification.
• PV System Validation: Computer System Validation (CSV) for safety platforms (e.g., Argus, ArisGlobal).
• Audit & Inspection Readiness: Mock audits, CAPA support, and documentation review.

✅ Benefits:

• Fully compliant and validated PV systems
• Streamlined, AI-enhanced safety operations
• Reduced audit risk and regulatory penalties
• Scalable, global delivery support

Core Services

• Safety Database Management: Configuration, maintenance, validation
• Clinical Safety & Signal Detection Support
• Software Development Life Cycle (SDLC) Consulting
• Validation Services:
  • AI & ML System Verification and Assessment
  • Automated Validation Processes
  • Full Suite of Validation Deliverables:
    • Master Validation Plan (MVP)
    • Validation Plan (VP)
    • Traceability Matrix (TM)
    • Validation Protocols
    • Risk & GAP Assessments
    • Validation Summary Reports (VSR)

Operational & Compliance Management

• Operational Oversight & Vendor Management
• Comprehensive Compliance Management:
  • User Access Reviews
  • Periodic Compliance Reviews
  • Data Backup & Restoration
  • Disaster Recovery Planning & Execution
• Internal Audits & Regulatory Inspections
• Regulatory Compliance Training & Awareness Programs

Strategic Services

• Strategic Partnerships & Project Leadership
• System Assessment & Vendor Selection Support
• Talent Acquisition for PV, Clinical, Regulatory, and Quality Roles
• End-to-End Project Collaboration Across Functions

Clinical Operations & Data Management

• Support for All Phases of Product Development
• Clinical Data Management Solutions:
  • Protocol Mapping Tool (PMT)
  • Electronic Case Report Forms (eCRF)
  • Electronic Data Capture (EDC) System Implementation and Support

Case & Medical Affairs Management

• Case Management System Implementation & Oversight
• Medical Affairs & Scientific Support
• Post-Marketing Surveillance (PMS) – Global, including NZ & Australia
• Tailored Process Solutions & Custom Workflows
• Process Automation & BOT Integration for Operational Efficiency

Quality Management & Audit

• Quality Management System (QMS) Development & Maintenance:
  • Standard Operating Procedures (SOPs)
  • Procedures, Work Instructions (WIs), Job Aids
• Audit Services & Ongoing Compliance Oversight