equilab news event

PT Equilab International GCP Inspection Statement From UK-MHRA

PT Equilab International was being inspected from 25th – 27th November 2014 by United Kingdom’s Medicines and Healthcare Products Regulatory Agency (UK-MHRA) for Good Clinical Practice (GCP) in bioequivalence study. The inspection assessed clinical, analytical, and management aspect. The objective of this inspection in order to assess the bioequivalence study for one of our sponsor’s products which will be registered and marketed in the UK.

After several months of assessment including the Corrective Action and Preventive Action (CAPA) preparation and review, Equilab received a closing statement from UK-MHRA on 19th May 2015. This accomplishment acknowledges Equilab as a global player in clinical study particularly in BA/BE study. It represents Equilab’s commitment to the quality of system, services, and its vision to become a global scale company in BA/BE and clinical trials.

Furthermore, to become global scale company in BA/BE study, Equilab has expanded its clinical site. Several numbers of bed has been added, additional floor has been acquired, and another additional facilities for clinical site to escalate volunteer’s comfort and to fulfill customers’ needs and satisfactions.