Designing a QMS that drives progress

A well-designed Quality Management System (QMS) is the backbone of an efficient, compliant, and inspection-ready organization.

If you are preparing for your first IND or expanding globally, your QMS must be structured to support where you are today while remaining adaptable for where you are headed tomorrow.

At G&L Scientific, we specialize in building fit-for-purpose, phase-appropriate QMS frameworks tailored to the unique needs of each client. With over 25 years of global experience across GxP environments, our team understands how to strike the right balance between compliance, practicality, and scalability.

Too often, early-stage companies slow operations by over-engineering their QMS or under-prepare, leaving gaps that surface during inspections or due diligence. A truly fit-for-purpose QMS is right-sized for your product, your team, and your development phase. As programs advance, the QMS can be expanded to incorporate change control, CAPA, audit and inspection readiness, document lifecycle management, and more.

Our QMS development services focus on creating systems that are not only compliant but also intuitive, sustainable, and constantly evolving. Core components include:

• SOP development and document control systems that are easy to implement and maintain
• Training frameworks that align staff competencies with compliance needs
• Clinical risk management planning to help identify and mitigate risks
• Deviation and CAPA processes designed for transparency and traceability
• Vendor oversight models that ensure third-party compliance
• Internal and external audit preparation to strengthen inspection readiness
• Data management, retention, and quality review practices to safeguard integrity

Whether you are working within GMP, GCP, GLP, or ISO standards, our team aligns your QMS with the appropriate regulatory frameworks, without overcomplicating what can be streamlined.

Our Integrated Product Development and Market Access Platform ensures that we don’t view our QMS services in isolation. Instead, we provide frameworks that support your clinical and regulatory strategy, connect with operational workflows, and anticipate the documentation and evidence required for future submissions and approvals.

Our QMS design often goes together with our Fractional Head of QA service, giving clients both the systems and the leadership needed to sustain quality as they grow.

A scalable QMS is one of the most valuable long-term investments a Sponsor can make and is one of the most common sources of delay when overlooked.

Learn more about our Quality & Compliance services, or get in touch to start designing your QMS with confidence.