Audit Services

Audits are Inevitable

Why Audit Services Matters

In regulated industries like pharma, biotech, and med device, audits aren’t optional—they’re expected. Whether you’re preparing for your first regulatory inspection or ensuring your suppliers meet quality standards, audit readiness is a must-have, not a nice-to-have.

At Sagax Team, we specialize in Internal Audits, Supplier Audits, and Audit Readiness for emerging life sciences companies. We help you identify gaps, strengthen your systems, and walk into audits with confidence.

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

Who We Help

Our Audit Services services are ideal for:

Get the right talent when you need it—our experts seamlessly extend your team for short- or long-term success!

Our Audit Services Process

Here’s how we help you stay ahead of compliance issues and ensure you’re always audit-ready:

Audit Readiness Services

We assess your current state through mock audits or gap assessments, helping you identify and correct issues before a regulator or customer finds them.

What We Deliver:

Internal Audits (GxP-Focused)

We plan and execute internal audits of your quality systems, processes, and records to ensure they meet both your SOPs and regulatory expectations.

Key Deliverables:

Supplier Audits

We audit your external vendors—such as CROs, CMOs, labs, and software providers—to verify that they meet quality and regulatory requirements.

What We Deliver:

Why Choose Sagax Team for Audit Services?

Industry-Tested Auditors

We bring real-world GxP experience and know how regulators think.

Risk-Based Approach

We prioritize findings based on potential impact—so you know where to act first.

Scalable to Your Needs

Fractional support, one-time engagements, or ongoing audit partnerships available.

Support Without Bureaucracy

We keep things practical, nimble, and focused on helping you succeed.

Tip: Don’t Wait Until You Get the Audit Notice

Most findings aren’t technical—they’re due to missing documentation, unclear responsibilities, or incomplete training. We help fix that before Day 1.

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.

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

Quality and Compliance

Lab Informatics

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