Lambda Therapeutic Research continues to demonstrate exceptional performance in regulatory compliance, marking its third successful US FDA inspection for Pharmacovigilance (PV) services in 2024, with zero findings. This milestone reflects Lambda’s unwavering commitment to delivering high-quality services and its “Always Inspection Ready” approach.
Inspection Details:
- Inspection Dates: December 16-19, 2024
- Notice of Inspection: One week prior, on December 10, 2024
- Client Location: East Coast, USA
- Time Zone Difference: Managed a 10.5-hour time zone difference between the US East Coast and India.
Despite the short notice and the time zone challenge, Lambda’s team provided comprehensive support, ensuring a seamless inspection process for the client. The inspection’s success with zero findings is a testament to Lambda’s robust operational procedures, rigorous quality controls, and commitment to maintaining the highest standards of compliance.
Key Takeaways:
- 3rd US FDA PV Inspection in 2024: A consistent record of excellence.
- Zero Findings: Further reinforcing Lambda’s “Always Inspection Ready” approach.
- Global Support: Effective management of time zone differences to support clients worldwide.
This achievement underscores Lambda Therapeutic Research’s role as a trusted partner in pharmacovigilance and clinical research, providing reliable, high-quality services across different regulatory environments and geographies.
Lambda Therapeutic Research, a leading global Clinical Research Organization (CRO), offers comprehensive drug safety and pharmacovigilance services across all clinical and post-marketing phases. Our established PV framework guarantees thorough safety monitoring and regulatory compliance for both clinical and commercial products, providing end-to-end support throughout the entire lifecycle of medicinal products.
