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. Our services are designed for fast paced environments and reduces the burden on our clients.
Assurea has presence in the US, Canada, UK and Europe. Assurea supports clients within biotech and pharmaceutical industries.

#BeAssured

Our Expertise

Phase 3 to Commercial: Biotech and CDMOs

For companies setting up operations and expanding their labs, we provide our full suite of services in QA and IT/CSV.

Clinical Startups

For clinical startups, we provide fractional Quality and IT/CSV services

  • 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
  • GxP system administration for manufacturing, lab and enterprise systems
  • User access management 
  • System maintenance
  • Blockchain and decentralized ledger implementation
  • Artificial intelligence and machine learning (AI/ML) data assessment and preparation
  • AI/ML validation 
  • Integrated lab platform validation
  • Regulatory compliance for novel technologies 
  • Third party vendor audits
  • Vendor management and supplier assessments
  • Vendor risk assessments

Always an A-Team

Our team can create, build, and scale frameworks for fast growing clients and has a proven track record. We have contributed to several industry guidelines and understand complex regulations in novel areas. Our approach is collaborative, accelerated, and practical.

For more information on our services, please contact us.