Why Assurea?
You’re always in control.

Assurea recognizes the fast-moving landscape of the biotech and pharmaceutical industry and that there is not a “one-fit-for-all” solution. We believe the flexible plans offers the best fit for reducing time and remaining cost effective, unlike traditional consulting which can be bureaucratic, require multiple consulting firms from various areas, and be less flexible and timely in delivering results. Assurea is available on-demand, and its experienced network of experts deliver quality services across multiple industry disciplines.


Our Expertise

Start up Quality Management System

  • Quality manual
  • Establishment and implementation of QMS
  • QMS and supplier audits
  • Inspection readiness program
  • Quality oversight
  • Quality procedures and policies

ATMPs/ Cell and gene therapy

  • Validation program
  • Quality considerations for plasmid and vector manufacturers
  • Process performance qualification
  • Ancillary studies and CMO considerations
  • Aseptic process simulation
  • Shipping Qualification
  • Process development and MSAT services

Emerging Technologies Compliance

  • Blockchain and decentralized ledger implementation
  • Regulatory compliance
  • Vendor management and supplier assessments
  • Risk Assessments

Data and IT Governance

  • DI governance, policies and procedures
  • Data maps and business process mapping
  • Risk assessment and vulnerability assessments
  • Computer software assurance and validation
  • Data integrity program and remediation
  • Security management and system administration
  • DI audits
  • DI training packages

With Assurea, Assurance doesn't have to be costly!

Our Plans


45 hours/month


65 hours/month


Custom Hours
Contact us

For custom hours and services, please  contact us.

Our Process

After you decide a plan, you can contact us, Assurea's team will schedule a call with you to go over project requirements. We can always help you select the best plan that fits your needs.