https://www.sikich.com

IT quality and compliance for life sciences

Purpose-built services for regulated innovation
In the highly regulated world of life sciences, quality and compliance are non-negotiable. Our IT quality and compliance services are designed to help you meet regulatory demands, enhance operational excellence and accelerate digital modernization.

Software assurance and validation services

We provide risk-based validation for GxP systems and applications. We deliver end-to-end software assurance from requirements to release. We offer digital validation frameworks for faster, paperless execution. We prepare audit-ready documentation aligned with global standards. Our services are ideal for the following software: ERP Systems (Oracle, SAP, Dynamics 365 and Salesforce), EQMS Systems (TrackWise, TrackWise Digital, Veeva, and Salesforce), MES, LIMS, EDMS, BMS, Laboratory/Instrument.

Specialized services for your compliance needs

FDA regulatory and GxP services

Our FDA regulatory and GxP services help you navigate complex regulations through technical procedural authoring, streamlined quality processes, and expert guidance on U.S. FDA requirements. We provide comprehensive support across QA services, audit services and regulatory consulting.

Compliance as a Service (CaaS)

Compliance as a Service (CaaS) offers scalable, managed compliance covering all aspects of validation and regulatory support. Engagements can be full-time or part-time, flexible and agile to meet your needs and budget, and structured as either fixed-fee or time-and-materials arrangements.

Testing as a Service (TaaS)

Testing as a Service (TaaS) enables organizations to accelerate quality through intelligent testing solutions. It offers flexible long-term and annual subscription models, providing a comprehensive range of services, including automated testing, manual testing and test management.

Why Sikich

Why life sciences leaders trust us

We bring decades of pharma, biotech and medtech experience, with proven regulatory expertise across FDA, EMA and global audits. Our agile, scalable delivery adapts to your priorities. As your compliance ally, we leverage partnerships with leaders like Tricentis, KNEAT and Compliance Insight to provide comprehensive, best-in-class services.
Contact us

Ready to simplify compliance and accelerate innovation?

Let’s build a quality-first digital ecosystem that’s audit-ready, future-proof and built for life sciences. Contact us today to learn how we can support your next initiative.