Quality Management
Build a Right-Sized QMS That Sets You Up for Long-Term Success
Why Quality Management Matters
For emerging and growing life sciences companies, a Quality Management System (QMS) is the foundation of compliance, product integrity, and operational consistency. But too often, companies adopt bloated systems designed for large enterprises—or worse, scramble to patch together documents only when an audit looms.
At Sagax Team, we help you build a fit-for-purpose QMS that’s scalable, compliant, and efficient. Whether you’re preclinical or scaling toward commercialization, we guide you through every step—without overengineering the solution.
Focus on your business—we'll handle the rest with end-to-end management and seamless support!
Who We Help
- Startups and emerging companies building a QMS from the ground up
- Teams preparing for their first inspection or ISO certification
- Organizations that need to upgrade or streamline an existing QMS
- Companies transitioning from paper-based to digital quality systems
- Leaders looking to instill a quality culture without slowing innovation
Get the right talent when you need it—our experts seamlessly extend your team for short- or long-term success!
Our Approach
Building a Fit-for-Purpose Quality Management Program
Assess Foundational IT Compliance
Before we build your QMS, we assess whether you have the basic IT controls in place. These are essential for ensuring secure data, audit readiness, and system reliability—even if they aren’t GxP by nature.
Define Purpose & Business Drivers
We identify what success looks like for you—compliance, speed to market, investor readiness, etc.—to guide QMS design.
Assess Regulatory Landscape & Risk
We evaluate applicable regulations (FDA, EMA, ISO, ICH) and tailor your QMS to product risk and geographic reach.
Design a Scalable Quality Framework
We create your quality manual, policies, SOP structure, and governance model aligned with your operating reality.
Align People, Roles & Culture
We define quality responsibilities, develop training plans, and promote cross-functional ownership of quality processes.
Implement Key Processes & Templates
We build and roll out critical QMS processes—Document Control, CAPA, Change Control, Training, etc.—with ready-to-use templates.
Laying the IT Groundwork for a Compliant QMS
Why Work with Sagax Team?
Deliverables May Include: Quality Manual & Policy, SOPs, Work Instructions & Templates, Training Strategy & Role Matrix, QMS Roadmap & Implementation Plan, eQMS platform selection support
Tailored to Your Stage
No overkill. We design your QMS based on what you actually need now—with room to grow.
Life Sciences Expertise
We understand FDA, EMA, ISO, and ICH guidelines—and how to meet them practically.
Speed Without Sacrificing Quality
Lean templates, repeatable processes, and experts who’ve done this dozens of times.
Flexible Engagement Models
Project-based, managed services, or fractional SME support—whatever works best for you.
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.
