Supporting a Quick-turn Project with Onsite and Virtual Healthcare Auditing Experts
Challenge
A growing biopharmaceutical company asked us to provide qualified resources to support them with an auditing project. They had unique requirements and a fast timeline, which led them to leverage our experienced team.
Solution
Beacon Hill Life Sciences deployed our experts, who worked virtually and at various client sites on short notice, to meet our client’s audit requirements. Our team experience included:
- Good clinical practice (GCP)
- Good manufacturing practice (GMP)
- Good laboratory practice (GLP)
- Pharmacovigilance (PV)
- Computer system validation (CSV)
Achievements
Based on our success in this project, we were retained for another auditing project and full-scale inspection readiness initiatives, including trial master file (TMF) review and investigator site readiness.
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