Consulting Solutions

Professional & Technical Services

The Spanos Group is comprised of a broad cross-section of leaders in the engineering, construction, and life sciences industries. As a team, we’ve built a reputation of supporting complex, mission-critical projects for customers across the globe, in both commercial and government sectors. Successfully operating within highly-regulated environments comes natural to us.

Life Sciences Projects

Navigate Complex Industry Regulations

Our global life science practice provides our clients with cost-effective, critical talent to address some of most complex regulatory affairs issues, FDA inspections/audit-readiness, and remediation of 483s, consent decrees and overall enterprise harmonization programs. By identifying and organizing the best talent for their workforce, our client solutions team is quickly able to assemble a deployable team, provide our clients with a comprehensive statement of work incorporating agreed upon milestones/deliverables, and provide locked-in pricing for our services. Our team of subject matter experts have spent the last 30 years supporting most of the leading organizations within the Life Sciences industry globally, including pharmaceutical manufacturers, medical device companies, and biotechs. Regardless of your strategic needs, we are here to help you address the opportunities and challenges of the constantly evolving global healthcare system.

Expertise Across the GxP

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21 CFR Part 11, 201/211, 58, 820

21 CFR Sub-Chapter 11

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Equipment, Utilities, Facilities

Commissioning/De-Commissioning

SCADA, LIMS, Control Services, BMS, BAS

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CSV Systems Compliance/Audits

Corporate CSV Guidelines, MVPs

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Let Us Help Manage Your Projects

Experience the Spanos Group LLC difference and speak to our team of consultants today. As a firm that focuses on providing revolutionary solutions, we go out of our way to ensure your project’s efficient operation from start to finish. Whether you need regulatory compliance advisory or business process optimization, we are the experts you can count on. Call us to learn more about our Life Sciences and Engineering Consultancy solutions.

FDA Quality Compliance Brief