Why Assurea?
You’re always in control.

Assurea recognizes the fast moving landscape of the life science industry and that there is not a “one-fit-for-all” solution. We believe our plans offers the best fit for reducing time and remaining cost effective.
Assurea has presence in the US, Europe, UK and India. Assurea supports clients within biotech and pharmaceutical industries.


Our Expertise

  • Provide quality oversight
  • Serve as a quality unit (including batch release)
  • Establish and implement QMS
  • Supplier management program and audits
  • Quality agreements with contract manufacturers (CMOs/CDMOs)
  • Provide training development for GxP, lab operation and data integrity
  • Inspection readiness program and audits
  • Implement computer system validation program
    • GxP impact assessment
    • CSV lifecycle document development (URS, validation plan and summary report, design specification,
      configuration specification, and risk assessments)
    • Operation of GxP applications
    • Validation of excel spreadsheets
  • Computer system validation for enterprise and laboratory systems
  • Provide computer system validation (CSV) to computer software assurance (CSA) transition
  • Develop and implement data integrity program
  • Create data maps for standalone and multisystem interfaces
  • Perform gap analysis and data integrity remediation
  • IT infrastructure design, implementation and qualification
  • Security management
  • Develop IT procedures and polices:
    • IT quality policy
    • Business continuity plan
    • Disaster recovery plans
    • Back up and restore procedures
    • IT access and authorization management
    • Patch management
    • Network operations & maintenance
    • Configuration management
    • IT periodic review
    • Archival and storage
    • IT change control management
    • Workstation configuration
  • Blockchain and decentralized ledger implementation
  • Validate integrated lab platforms
  • Regulatory compliance
  • Vulnerability assessments
  • Vendor management and supplier assessments
  • Vendor risk assessments

Always an A Team

Our team can create, build, and scale frameworks that are phase appropriate for fast growing clients. We have contributed to several industry guidances and understand complex regulations within novel areas. Our approach is collaborative, accelerated, and practical.

For more information on our services, please contact us.