Inspection Readiness
Meet regulatory expectations, minimize potential findings and streamline the inspection process
Inspection Readiness
Meet regulatory expectations, minimize potential findings and streamline the inspection process
Preparing for success in regulatory review
Regulatory inspections by competent authorities are vital components in ensuring compliance and quality in the pharmaceutical industry.
As a key partner to drug development organizations, G&L has supported numerous regulatory inspections across different health authorities (including FDA, EMA, PMDA, Health Canada, etc.) by implementing strategies tailored to each client’s objectives, helping them achieve faster approval and maximize ROI.
We offer a range of remote and on-site inspection readiness services, implemented in a flexible and scalable manner that enables your team to confidently demonstrate alignment with regulatory expectations, minimize potential findings and streamline the inspection process.
Services include:
- Protocol inception
- Study plans and clinical SOPs development/updates
- Data review
- Adherence to clinical operations requirements (clintrials.gov, EudraCT)
- Monitoring
- Co-monitoring support
- Site management
- Ethics committees submissions
- Study start-up
- Gap assessments
- Clinical sites preparation
- Sponsor readiness
- Mock inspections
- Assistance during Sponsor and clinical study site inspections
- Assistance with inspection responses
Case study
Inspection readiness support
"G&L took a structured approach to ensure the client’s readiness for regulatory inspections"
