Theoris Life Sciences

A Division of Theoris, Inc.

Midwest value and international experience

FDA regulated industries are subject to constantly changing regulations that can drastically impact the risks of doing business. Methods that have met FDA scrutiny in the past few years are not necessarily adequate today. Helping you to manage your business within this environment is our specialty.

Theoris Life Sciences brings a third-party perspective driven by 20 years of hands-on professional services experience in Pharmaceutical, Medical Device, Nutritional, and Biotech environments. We specialize in designing a “right sized” compliance strategy that will stand up to FDA scrutiny by bringing a wealth of experience, knowledge, tools, and methods to assist you with:

  • Third-Party Audits, Compliance Assessments, and Gap Analyses
  • Warning Letter and other FDA Inspection Remediation Services
  • Functional Outsourcing Services in Validation, Software QA, and Documentation Services
  • New product support for 510K, PMA, NDA/ANDA as well as other Regulatory Submissions
  • All forms of Validation: Process, Equipment, Software (CSV), Laboratory, Manufacturing, Cleaning, Clean Room, and Utilities
  • Customized Regulatory and Quality Training Services including all cGXP, FDA, ICH, GHTF Guidelines/Regulations, and ISO standards
  • Technology Development and Enablement Services for Custom and Package Software
  • Theoris Vision Software™ – we can rapidly deploy a software solution to provide enterprise visibility to your Compliance and Quality Metrics utilizing Dashboards to monitor performance, metrics, and balanced scorecards in regulated environments

Theoris Life Sciences utilizes risk-based strategies, methods, approaches, and software to assess and solve your business needs with innovative solutions for Medical Device, Pharmaceutical, Nutritional/Foods, Biotech, and Healthcare companies. Our experience spans a wide variety of manufacturing, clinical, laboratory (cGxP) environments including quality systems consulting, all forms of validation, and regulatory solutions including FDA, 21 CFR Part 820, 210, 211; ISO Standards including 13485 and the new guidance for 21 CFR Part 11 and HIPAA.

From complete outsourcing to validated technology solutions, we are focused on assisting you in meeting your business needs. Please contact us at our headquarters offices, or email us at or contact: Lynn Spartz, Business Development Manager, 877-623-8742.

A new Theoris Life Sciences website is coming soon. Stay tuned for more information about our services, software, experience, and career opportunities