Quality & Compliance

Supporting Quality-Driven Growth for Regulated Companies

Building Quality That Scales

In the life sciences industry, quality is not just a checkbox—it’s the foundation of trust, safety, and regulatory success. Our Quality & Compliance services are designed to help emerging and growth-stage pharma, biotech, and med device companies establish scalable, inspection-ready quality systems that align with FDA, EMA, ISO, and ICH guidelines.

We bring deep domain knowledge, practical implementation experience, and flexible support models—so you can stay focused on innovation while we help you build a compliant, sustainable future.

Focus on your business—we'll handle the rest with end-to-end management and seamless support!

Tailored Support for Regulated Teams

Our services are built for quality, compliance, and IT leaders in regulated companies—especially those in early growth or transition phases.

We’re a good fit if:

Our flexible engagement models—consulting, managed services, and staff augmentation—allow us to meet you where you are
Get the right talent when you need it—our experts seamlessly extend your team for short- or long-term success!

Why Choose Our Quality & Compliance Services?

Deep Life Sciences Expertise

Our team understands regulatory expectations and industry nuances—especially in emerging companies.

Comprehensive & Scalable

From simple SOP development to full eQMS implementation, we deliver solutions that grow with you.

Efficient & Cost-Effective

We optimize your path to compliance without unnecessary overhead or bloated timelines.

Proven Track Record

We’ve supported companies through successful FDA inspections, vendor audits, and digital transformations.

Educational Insight

Why Quality Systems Matter

For regulated companies, quality systems aren’t just operational—they’re strategic. A well-structured QMS protects patient safety, ensures product integrity, and builds the trust of regulators and investors alike. Failing to invest in quality early can lead to expensive delays, failed audits, and reputational harm.

What Our Clients Say

Our clients trust us to deliver effective, compliant, and results-driven solutions for the life sciences industry. See what they have to say about working with Sagax.

The support was excellent. Sagax took the time to hear what we didn’t like about our current situation and offered alternative LIMS solutions that specifically addressed these pain points

Anthony Grilli​

CEO Focus Labs​

Sagax Team's consulting services demonstrated excellent support and their consultant executed the validation of the Azure GxP instance with proficiency. The quality of their work was highly satisfactory, the project was completed on time and within budget. This team has excellent proficiency and work ethics. Thanks! Sagax team

Faeq Mansour​

Sr. Director IT, Growing Biotech​

Sagax has been an effective partner in providing resourcing for my team. The quality of consultants has enabled me to build out a best-in-class team. Would use Sagax services again and highly recommend!

Kent Johnson​

Associate Director, Clinical Operations, Arcus Biosciences​

We have used Sagax Team for staff augmentation as well as to support a LIMS migration. We have found their consultants to always be a near perfect fit for the task. Whether it is technical specialists, project managers, business analysts, master data specialists, they have always delivered.

Franky Choi​

Head of PMO, Large Biotech Firm​

Sagax Team are industry experts in the niche field of GMP IT support. Sagax team has delivered both large scale and smaller scale LIMS implementations. Their team are partners throughout the project lifecycle- from feasibility, business process mapping, implementation, project management and validation. They deliver a quality compliant system that work for end users. Their team listens to the needs of clients and can present industry best practices recommendations and solutions. I highly recommend Sagax Team for any GMP IT support project.

Kathy Zagaroli​

Senior Director, Quality Control, Kiniksa Pharmaceuticals​

Sagax Team is my go-to vendor for computerized systems validation, computer software assurance assessment, data integrity gap remediation, IT infrastructure engineering, and Laboratory Information Management System (LIMS) Software Lifecycle (SLC) services: project management, business analysis, requirements specification, configuration, validation, administration, and data management. They have become my first-choice vendor because they have repeatedly achieved high-quality, efficient delivery, under aggressive timelines, no matter the circumstances. They provide industry-leading expertise, wise counsel, excellent partnership, and extremely positive, can-do attitudes. Their resources work well independently and integrate seamlessly with cross-functional business teams across all organizational levels. I unequivocally recommend them for regulated computer systems services and LIMS projects.

Gudrun Finn

Sr. IT Executive, Biotech​

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