Proven Compliance - Consistently pass audits with infrastructure aligned to current regulations
Expert Support - Professional services team with Lab, Clinical, and Manufacturing validation experience
Audit-Ready - Leveraged by institutional auditors and firms across the industry
Scalable Solutions - From pre-commercial startups to global commercialized companies
Focus on Your Core Business - We handle GxP infrastructure so you can focus on innovation
Receive comprehensive GxP-compliant infrastructure and regulatory support services for medical device companies, from secure document management and FDA cybersecurity submissions to validated cloud infrastructure and audit defense.
A pre-qualified, audit-ready infrastructure that accelerates customer deployments and shortens sales cycles.
Get Pre-sales auditability by potential clients and RFP support.
Enter the GxP world cost-effectively with Quality System as a Service and guidance from Phase II through regulatory readiness.
Start at the finish line with a mature comprehensive truly GxP service.
Partner with the GxP cloud leader your clients already trust to free up resources for high-impact activities.
Scale GxP systems efficiently with hybrid-cloud infrastructure that reduces costs as you grow.
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