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, Europe and the Middle East. Assurea supports clients within biotech, pharmaceutical and medical device 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.

Software 

Assurance

For software companies, we provide certification preparation (e.g. ISO27001, ISO13485), supplier assessments, vendor IOQ packages, and 3rd party audits.

Clinical Startups

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

AI Solutions

Optimize current workflows with AI and decentralized solutions designed specifically for the biotech industry

  • Certification prep (e.g. ISO 27001, 9001, 13485)
  • Provide quality oversight
  • Establish and implement QMS
  • Supplier management program and audits
  • Quality agreements with contract manufacturers (CMOs/CDMOs)
  • 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
  • AI governance and compliance frameworks
  • Artificial intelligence and machine learning (AI/ML) validation for AI tools and software platforms
  • Certification preparations and audit readiness
  • Documentation analysis and review (e.g. shipping validation, annual product review, vendor documentation and turn-over packages)
  • Creation of Interactive SOPs
  • Blockchain and decentralized ledger implementation
  • Custom AI Agents development (e.g. to automate tasks like inventory management, document review, and continuous monitoring)

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.