Lambda Therapeutic Research successfully clears another European Medicines Agency (EMA) Inspection for two PK studies in Oncology on Metastatic Breast Cancer and Ovarian Cancer patients
11 Dec 2021
It is with great pride we announce that we have successfully cleared an important EMA inspection for a PK study in Oncology segment on Metastatic Breast Cancer and Ovarian Cancer patients by DKMA [Danish Medicines Agency, Denmark] and INFARMED [National Authority of Medicines and Health Products, Portugal]. We also had the unique privilege of having the USFDA inspectors participate in the same Inspection since they were invited by the EMA Authorities as observers.
Overall, the inspection was conducted in two phases of which the 1st Phase (28 to 30 June 2021) was a virtual inspection; wherein our IT systems were meticulously reviewed and the 2nd Phase (18 to 29 Oct 2021) comprised of a physical onsite inspection of our clinical Sites and bioanalytical facilities.
Besides being another glittering testament to the consistently high quality standards of Clinical Research services provided to our Global clientele, this milestone also reinforces Lambda's commitment to uncompromising compliance with global regulations and guidelines for Good Clinical Practice (GCP).
We look forward to your continued patronage to achieve more milestones of quality excellence in the global Clinical Research landscape.