Overview

G&L Healthcare Advisors was engaged to provide inspection readiness support for a client preparing for regulatory inspections by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA).

The client’s studies were essential to the New Drug Application (NDA) for an orphan drug used to treat a rare disease. 

G&L developed a comprehensive Inspection Project Plan that involved coordination across teams and stakeholders, verification of responsibilities, creation of key project deliverables, and preparation for both sponsor and investigator site inspections.

Challenges

The client faced several significant challenges in preparing for the upcoming inspections. These challenges were compounded by the involvement of multiple regulatory agencies, diverse stakeholder groups, and the necessity for stringent compliance with regulatory standards and included:
Global regulatory scope: The client was facing inspections from three major regulatory agencies (FDA, EMA, and PMDA), each with its unique requirements and standards, adding complexity to the preparation process.
Coordination of multiple stakeholders: The inspection readiness process required coordination between various teams, including the Sponsor, Contract Research Organization (CRO), vendors, and investigator sites. Ensuring that all parties were aligned in terms of documentation, access, and inspection requirements was a key challenge.
Ensuring compliance and preparedness across two studies: Two pivotal studies were involved in the NDA, and ensuring that all Standard Operating Procedures (SOP)-specified deliverables and essential documentation were appropriately filed and accessible was critical to the success of the inspections.
Training and resource management: The client needed to ensure that all stakeholders were properly trained, and the project resourcing was aligned with the specific inspection preparation needs while maintaining oversight of potential risks and issues.

G&L’s Approach and Solution

Within this engagement, G&L took a structured approach to ensure the client’s readiness for regulatory inspections. Key activities included:
Comprehensive inspection readiness activities: G&L completed all necessary inspection readiness tasks, ensuring that corresponding training documentation was filed and accessible for all team members, including the client, CRO, and vendors.
Clinical system management: G&L ensured the availability of clinical systems for the two studies, along with rosters of individuals with access to start/stop dates. G&L also ensured that standard reports for each study were collected before the inspection.
SOP and documentation review: The team identified and ensured that SOPs followed for each activity in each study were in compliance and that all required documentation was properly filed and accessible for inspection.
Mock inspections and investigator site preparation: G&L performed a mock inspection to test the client’s inspection readiness and prepared investigator sites for their upcoming inspections. Additionally, G&L supported the development of narratives and storyboards to facilitate clear communication during inspections.
Collaboration and communication: Ongoing collaboration and communication with key vendors ensured that inspection preparation expectations were aligned, and any documentation requirements or deliverables were tracked.
CAPA review: G&L reviewed Corrective and Preventive Actions (CAPAs) to ensure all commitments were implemented for each study, further solidifying the client’s compliance before the inspection.

Impact and Outcomes

As a result of G&L’s thorough preparation and collaborative approach:
Successful inspections: The client successfully passed all inspection activities, including both Sponsor and Investigator Site inspections.
Agency approval: The orphan drug received approval from all three regulatory Agencies (FDA, EMA, and PMDA).
Compliance issues mitigated: G&L’s inspection readiness support ensured that the client was fully prepared for regulatory scrutiny, avoiding delays and potential compliance issues.