Purpose-Built Services for Regulated Innovation
In the highly regulated world of Life Sciences, quality and compliance are non-negotiable. Our IT Quality & Compliance services are purpose-built to help you meet regulatory demands while driving operational excellence and accelerating modernization across your digital landscape.
Software Assurance & Validation Services
Delivering confidence in every deployment with end-to-end support:
- Risk-based validation for GxP systems and applications
- End-to-end software assurance from requirements to release
- Digital validation frameworks for faster, paperless execution
- 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 & GxP Services
Navigate complex regulations with technical procedural authoring, quality process simplifications and U.S. FDA:
- QA Services
- Audit Services
- Regulatory Consulting Services
Compliance as a Service (CaaS)
Scalable compliance, delivered as a managed service covering all aspects of validation and regulatory support:
- Full-time or part-time engagements
- Scalable and agile to meet customer need and budget
- Fixed fee or T&M engagements
Testing as a Service (TaaS)
Accelerate quality with intelligent testing. Flexible long-term and annual subscription models are available to provide:
- Automated testing
- Manual testing
- Test management
Strategic Partnerships
Why Life Sciences Leaders Trust Us
Deep Domain Expertise: Decades of experience across pharma, biotech, and medtech
Regulatory Precision: Proven success with FDA, EMA, and global audits
Agile & Scalable Delivery: Flexible models to meet your pace and priorities
Strategic Partnerships: From roadmap to remediation, we’re your compliance ally. We’ve formed partnerships with industry leaders to bring best-in-class, comprehensive services to your organization. (Tricentis, KNEAT, Compliance Insight)
