Regulatory

Regulatory

Cliantha Research has been successfully inspected or audited by various regulatory agencies. Our team works hard to maintain high quality and strict adherence to the applicable standard(s) and guidelines like ICH, FDA, EMA, GCP and GLP. The Cliantha team uses sound science as a foundation for our planning and execution plus a robust knowledge of the regulations. Our internal training systems provide for consistent and regular training of the Cliantha staff. Cliantha continually reviews and assesses the best approach reflecting the current requirements. Information related to Clinical Trial Sites regulatory inspections can be found in the Clinical Trial Management section.

Our track record can be seen below:

Ahmedabad HQ & Sigma by UK MHRA (Clinical & Bio-Analytical)

2017 April 24 – 28
2017 March 20 – 23

Ahmedabad HQ
by US FDA (Clinical)

Ahmedabad Sigma
by US FDA (Clinical)

2017 March 14 – 27
2016 April 25 – May 3

Ahmedabad HQ
by USFDA (Bio-Analytical)

Ahmedabad HQ
by US FDA (Clinical)

2016 Jan 18 – 22
2015 Mar 23 – Apr 3

Ahmedabad Sigma
by US FDA (Clinical)

Ahmedabad HQ
by US FDA (Clinical & Bio-Analytical)

2014 May 19 – 23
2014 Jan 20 – 24

Ahmedabad HQ
by US FDA (Clinical)

Ahmedabad HQ
by Thai MoPH (GLP)

2013 Jul 15 – 18
2013 Apr 9 – 11

Ahmedabad HQ and Sigma
by Turkey MoH (GLP & GCP)

Ahmedabad HQ and Vadodara
by WHO (Clinical & Bio-Analytical)

2013 Mar 19 – 22
2013 Feb 25 – Mar 1

Ahmedabad HQ by UK MHRA (Clinical & Bio-Analytical)

Ahmedabad HQ and Sigma
by WHO (Clinical & Bio-Analytical)

2012 Jun 19 – 22
2011 Apr 13 – 15

Ahmedabad HQ by Spanish Agency (Bio-Analytical)

Ahmedabad HQ
by USFDA (Clinical)

2010 Oct 25 – 27
2010 Oct 18 – 22

Ahmedabad Sigma
by USFDA (Clinical)

Ahmedabad HQ
by WHO (Clinical & Bio-Analytical)

2010 Oct 18 – 20
2010 Jun 17 – 23

Ahmedabad HQ
by USFDA (Bio-Analytical)

Ahmedabad HQ
by MCC (Clinical & Bio-Analytical)

2009 Jan 12 – 13
2007 Sep 20 – 21

Ahmedabad HQ
by US FDA (Clinical & Bio-Analytical)

Ahmedabad HQ
by USFDA (Clinical)

2007 May 14 – 17
2006 Nov 06 – 11

Ahmedabad HQ by AFSSAPS (ANSM) (Clinical & Bio-Analytical)

Diagnostic Lab
Cliantha
HQ
  • CAP Sept 2007
Cliantha
Vadodara
  • CAP Sept 2015
  • CAP Sept 2013
  • CAP Aug 2011
  • CAP Sept 2010
  • CAP Sept 2008
Cliantha
SIGMA
  • NABL Oct 2016
  • CAP Sept 2015
  • CAP Sept 2013
  • ANVISA July 2012
  • CAP Aug 2011
  • CAP Sept 2009

All the four locations of Cliantha Research Limited - Ahmedabad HQ, Ahmedabad Sigma, Vadodara & Noida are approved by Drug Controller General of India (DCGI).

Regulatory Inspections

Goverment of India Facilities inspected & approved by Drugs Controller General of India
Last inspection in Nov 2015 by
Austria (2 times)
Inspected facility in Nov 2006 by
ANSM
Inspection facility in jan 2009 by
MCC
Last inspection in March 2017 by
USFDA (17 times)
Last inspection in April 2017 by
UK MHRA (2 times)
Last inspection in March 2013 by
WHO (3 times)
Inspected facility in July 2013 by
Thai MOH
Last inspected by Ministry of Health of Turkey in April 2013
Inspected facility in April 2011 by
Spain