Inspection-ready and ready to respond

Routine or triggered, announced or unannounced, regulatory inspections are inevitable.

While they place quality systems under the microscope, it is the response to them, both before and after, that can define a program’s trajectory.

At G&L Scientific, we provide support on both sides of the inspection table, helping clients prepare with confidence and recover with clarity.

With over 25 years of global Quality Assurance (QA) experience, our team understands the importance of being both inspection-ready and remediation-capable.

Inspection-readiness begins long before a notice arrives.

With this in mind, we collaborate with Sponsors and clinical teams to build inspection preparedness into day-to-day operations and ensure they are not a last-minute scramble.

This includes conducting mock inspections, data integrity audits, reviewing SOPs and training records, assessing Trial Master File (TMF) health, preparing study documentation, and coordinating site-level and sponsor-level readiness training.

We also support teams in developing storyboards and narratives, managing stakeholder alignment, and ensuring that all documentation is accessible, compliant, and inspection-ready.

Even so, the most prepared organizations can still face scrutiny, and when that happens, response time and approach matter.

Our remediation services are designed to move teams from audit gaps to long-term gains through root cause analysis, CAPA development, implementation, and effectiveness checks, SOP updates, corrective training, and documentation support. We help manage timelines, support communication with regulatory agencies, and ensure that every action taken reinforces quality and compliance.

Regardless of your situation, G&L offers strategic insight and direct expertise to help you move forward. Our inspection readiness and remediation services are part of a broader Product Development and Market Access Platform, meaning your quality strategy is never siloed.

Instead, it is aligned with your clinical and regulatory goals and built to grow with you.

If you are ready to strengthen your inspection strategy or recover from recent findings, we are here to help.

Explore our Quality & Compliance services or get in touch today to start a conversation.