Regulatory

Cliantha Research has been successfully inspected or audited by various regulatory agencies across the globe. Our impeccable regulatory track record is the result of strict adherence to the applicable standard(s) and guidelines laid by ICH, FDA, EMA, Clinical and Bioanalytical bodies. Our enshrined values : Science & Integrity are the foundation for our planning and execution assisted with robust knowledge of the regulations.


  • Clinic
  • Bioanalytical
  • Multicentric Sites
  • Clinical Lab
  • Regulatory Affairs Services

Clinic

Sr. No Agency Inspection Date Country Location
1 USFDA 16 Jul -19 Jul 2019 India Ahmedabad (HQ)
2 USFDA 15 Jul -19 Jul 2019 India Vadodara
3 USFDA 24 Jun -28 Jun 2019 USA St. Petersburg, FL site
4 USFDA 29 Oct - 2 Nov 2018 Canada Mississauga, Ontario
5 USFDA 25 Jul - 31 July 2018 USA New Jersey
6 WHO 25 Jun - 29 Jun 2018 India Ahmedabad HQ & Sigma
7 USFDA 05 Mar - 09 Mar 2018 India Noida
8 AEMPS 28 Jun - 30 Jun 2017 Canada Mississauga, Ontario
9 USFDA 03 May - 19 May 2017 USA St. Petersburg, FL 
10 MHRA 24 Apr - 28 Apr 2017 India Ahmedabad HQ & Sigma
11 Health Canada 18 Apr - 19 Apr 2017 Canada Mississauga, Ontario
12 USFDA 20 Mar - 23 Mar 2017 India Ahmedabad HQ
13 USFDA 14 Mar - 17 Mar 2017 India Ahmedabad Sigma
14 DEA 22 Feb - 01 Mar 2017 USA St. Petersburg.FL
15 USFDA 28 Nov - 02 Dec 2016 India Vadodara
16 USFDA 14 Nov - 17 Nov 2016 Canada Mississauga, Ontario
17 Health Canada 21 Mar - 28 Mar 2016 Canada Mississauga, Ontario
18 USFDA 14 Mar - 17 Mar 2016 Canada Mississauga, Ontario
19 USFDA 19 Jan – 19 Feb 2016 USA St. Petersburg, FL 
20 USFDA 18 Jan - 22 Jan 2016 India Ahmedabad HQ
21 USFDA 11 Jan - 19 Jan 2016 USA St. Petersburg, FL 
22 AGES 03 Nov - 05 Nov 2015 India Vadodara
23 USFDA 15 June - 18 June 2015 Canada Mississauga, Ontario
24 USFDA 23 Mar - 03 Apr 2015 India Ahmedabad Sigma
25 USFDA 03 Nov - 06 Nov 2014 Canada Mississauga, Ontario
26 USFDA 18 Aug - 22 Aug 2014 India Vadodara
27 Health Canada 21 July - 25 July 2014 Canada Mississauga, Ontario
28 USFDA 19 May - 23 May 2014 India Ahmedabad HQ
29 Health Canada  26  Mar 2014 Canada Mississauga, Ontario
30 USFDA 20 Jan - 24 Jan 2014 India Ahmedabad HQ
31 USFDA 24 Jun - 28 Jun 2013 India Vadodara
32 TURKEY MoH 09 Apr - 11 Apr 2013 India Ahmedabad HQ & Sigma
33 WHO 19 Mar - 22 Mar 2013 India Ahmedabad HQ & Vadodara
34 MHRA 25 Feb - 01 Mar 2013 India Ahmedabad HQ
35 WHO 19 Jun - 22 Jun 2012 India Ahmedabad HQ & Sigma
36 USFDA 03 Oct - 07 Oct 2011 India Vadodara
37 AEMPS 11 Apr - 15 Apr 2011 India Ahmedabad HQ & Vadodara
38 AGES 09 Feb - 10 Feb 2011 India Vadodara
39 USFDA 25 Oct - 27 Oct 2010 India Ahmedabad HQ
40 USFDA 18 Oct - 22 Oct 2010 India Ahmedabad Sigma
41 WHO 18 Oct - 20 Oct 2010 India Ahmedabad HQ
42 MCC 12 Jan - 13 Jan 2009 India Ahmedabad HQ
43 USFDA 15 Sept - 19 Sep 2008 India Vadodara
44 USFDA 20 Sept - 21 Sep 2007 India Ahmedabad HQ
45 USFDA 14 May - 17 May 2007 India Ahmedabad HQ
46 ANSM 6 Nov - 11 Nov 2006 India Ahmedabad HQ
47 USFDA 2011 USA Miamiville
48 USFDA 2011 USA St. Petersburg, FL 
49 USFDA 2011 USA Miamiville

Bioanalytical

Sr. No Agency Inspection Date Country Location
1 USFDA 12 Aug - 16 Aug 2019 Canada Toronto, Ontario
2 USFDA 30 Jul - 03 Aug 2018 India Ahmedabad HQ & Sigma
3 WHO 25 Jun - 29 Jun 2018 India Ahmedabad HQ & Sigma
4 AEMPS 16 Nov - 20 Nov 2017 Canada Toronto, Ontario
5 Health Canada 15 Jun 17 Canada Toronto, Ontario
6 USFDA 15 May - 19 May 2017 Canada Toronto, Ontario
7 MHRA 24 Apr - 28 Apr 2017 India Ahmedabad HQ & Sigma
8 Health Canada 27 Apr - 28 Apr 2016 Canada Toronto, Ontario
9 USFDA 25 Apr - 03 May 2016 India Ahmedabad HQ
10 Health Canada 02 Mar 16 Canada Toronto, Ontario
11 USFDA 19 May - 23 May 2014 India Ahmedabad HQ
12 THAILAND MoPH 15 July - 18 Jul 2013 India Ahmedabad HQ
13 TURKEY MoH 09 Apr - 11 Apr 2013 India Ahmedabad HQ & Sigma
14 WHO 19 Mar - 22 Mar 2013 India Ahmedabad HQ & Vadodara
15 MHRA 25 Feb - 01 Mar 2013 India Ahmedabad HQ
16 WHO 19 Jun - 22 Jun 2012 India Ahmedabad HQ & Sigma
17 AEMPS 11 Apr - 15 Apr 2011 India Ahmedabad HQ
18 WHO 18 Oct - 20 Oct 2010 India Ahmedabad HQ
19 USFDA 17 Jun - 23 Jun 2010 India Ahmedabad HQ
20 MCC 12 Jan - 13 Jan 2009 India Ahmedabad HQ
21 USFDA 20 Sept - 21 Sep 2007 India Ahmedabad HQ
22 ANSM 6 Nov - 11 Nov 2006 India Ahmedabad HQ

Multicentric Sites

12 consecutive inspections with no form 483

Sr. No. Agency Inspection Date Country Location Specialty
1 USFDA 18 Nov - 22 Nov India Mumbai Dermatology & Orthopedics
2 USFDA 18 Nov - 21 Nov India Ahmedabad Orthopedics
3 USFDA 11 Nov - 15 Nov 2019 India Vijaywada Neuropsychiatry
4 USFDA 11 Nov - 15 Nov 2019 India Pune Neuropsychiatry
5 USFDA 4 Nov - 8 Nov 2019 India Hubli Immunology
6 USFDA 4 Nov - 8 Nov 2019 India Pune Neuropsychiatry
7 USFDA 4 Nov - 8 Nov 2019 India Nashik Dermatology
8 USFDA 21 Oct – 25 Oct 2019 India Mumbai Dermatology
9 USFDA 11 Sep - 14 Sep 2019 India Junagadh Neuropsychiatry
10 USFDA 02 Sep - 06 Sep 2019 India Ahmedabad Orthopedics
11 USFDA 13 Aug - 20 Aug 2019 India Ahmedabad Dermatology & Orthopedics
12 USFDA 29 Jul - 02 Aug 2019 India Ahmedabad Neuropsychiatry
13 USFDA 05 Mar - 07 Mar 2019 India Mumbai Dermatology
14 USFDA 05 Feb - 08 Feb 2019 India Lucknow Dermatology
15 USFDA 14 Nov - 16 Nov 2018 India Lucknow Dermatology
16 USFDA 17 Sept - 20 Sept 2018  India Himmatnagar   Osteoarthritis
17 USFDA 30 May – 01 Jun 2018 India Pune  Neurology
18 USFDA 28 May – 05 Jun 2018 India Gandhinagar  Neurology
19 USFDA 11 Apr - 13 Apr 2018 India Goa  Oncology
20 USFDA 12 Mar - 16 Mar 2018 India Bangalore  Oncology
21 USFDA 16 Jan - 18 Jan 2018 USA Omaha, Nebraska, USA Dermatology
22 USFDA 11 Dec - 13 Dec 2017 India Mumbai Dermatology
23 USFDA 04 Dec - 06 Dec 2017 India Bangalore Dermatology
24 USFDA 15 Nov - 18 Nov 2017 India Ahmedabad Psychiatry
25 USFDA 20 Feb - 24 Feb 2017 India Pune Psychiatry
26 USFDA 23 Jan - 26 Jan 2017 India Junagadh Psychiatry
27 USFDA 07 Nov - 10 Nov 2016 India Surat Neurology
28 USFDA 15 Aug - 19 Aug 2016 India Pune Neurology
29 USFDA 08 Aug - 12 Aug 2016 India Gandhinagar Neurology
30 USFDA 25 Aug - 28 Aug 2014 India Vadodara Oncology
31 USFDA 28 July - 31 Jul 2014 India New Delhi Oncology
32 USFDA 24 Mar - 27 Mar 2014 India Madurai Oncology
33 USFDA 24 Feb - 27 Feb 2014 India Nagpur Oncology

Clinical Lab

Sr. No Regulatory Agency Inspection Country Location
1 CAP Sep-19 India Ahmedabad Sigma & Vadodara
2 NABL Feb-19 India Ahmedabad Sigma
3 CAP Jan-18 India Noida
4 NABL Oct-17 India Ahmedabad Sigma
5 CAP Sep-17 India Ahmedabad Sigma & Vadodara
6 NABL Oct-16 India Ahmedabad Sigma
7 CAP Sep-15 India Ahmedabad Sigma & Vadodara
8 CAP Sep-13 India Ahmedabad Sigma & Vadodara
9 NABL Aug-13 India Ahmedabad Sigma
10 ANVISA Jul-12 India Ahmedabad Sigma
11 CAP Aug-11 India Ahmedabad Sigma & Vadodara
12 CAP Sep-10 India Vadodara
13 CAP Sep-09 India Ahmedabad Sigma
14 CAP Sep-08 India Vadodara
15 CAP Sep-07 India Ahmedabad HQ

Regulatory Affairs Services

Cliantha Canada Regulatory Team Capabilities

Cliantha Canada regulatory team based at Mississauga location is a dedicated team of professionals with specialization in providing the following niche services in the regulatory domain:

  • Pre-IND packages
  • IND submission preparation
  • ITA submission
  • Client support for medical device license application for Health Canada

For more information click here