The FCRL facility has recently been inspected by the French Regulatory authority, AFSSAPS. It underwent a successful audit for two studies submitted to France and Denmark. The inspection covered all aspects of the study related activities- besides facility & quality systems audit.
ANVISA (Brazil)
Approved as a GCP-compliant site for clinical, bioanalytical and statistical support for BA/BE studies.
DCGI (India)
Approved by Drugs Controller General of India (DCGI) to conduct clinical studies with the new Drugs.
DSIR (India)
Approved as a research centre by Department of Scientific and Industrial Research (DSIR), Govt. of India.
Apart from these regulatory authorities, FCRL has been approved by a number of national and international pharmaceutical companies.
