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 02 Dec - 06 Dec 2019 India Ahmedabad (Sigma)
2 USFDA 16 Jul -19 Jul 2019 India Ahmedabad (HQ)
3 USFDA 15 Jul -19 Jul 2019 India Vadodara
4 USFDA 24 Jun -28 Jun 2019 USA St. Petersburg, FL site
5 USFDA 29 Oct - 2 Nov 2018 Canada Mississauga, Ontario
6 USFDA 25 Jul - 31 July 2018 USA New Jersey
7 WHO 25 Jun - 29 Jun 2018 India Ahmedabad HQ & Sigma
8 USFDA 05 Mar - 09 Mar 2018 India Noida
9 AEMPS 28 Jun - 30 Jun 2017 Canada Mississauga, Ontario
10 USFDA 03 May - 19 May 2017 USA St. Petersburg, FL 
11 MHRA 24 Apr - 28 Apr 2017 India Ahmedabad HQ & Sigma
12 Health Canada 18 Apr - 19 Apr 2017 Canada Mississauga, Ontario
13 USFDA 20 Mar - 23 Mar 2017 India Ahmedabad HQ
14 USFDA 14 Mar - 17 Mar 2017 India Ahmedabad Sigma
15 DEA 22 Feb - 01 Mar 2017 USA St. Petersburg.FL
16 USFDA 28 Nov - 02 Dec 2016 India Vadodara
17 USFDA 14 Nov - 17 Nov 2016 Canada Mississauga, Ontario
18 Health Canada 21 Mar - 28 Mar 2016 Canada Mississauga, Ontario
19 USFDA 14 Mar - 17 Mar 2016 Canada Mississauga, Ontario
20 USFDA 19 Jan – 19 Feb 2016 USA St. Petersburg, FL 
21 USFDA 18 Jan - 22 Jan 2016 India Ahmedabad HQ
22 USFDA 11 Jan - 19 Jan 2016 USA St. Petersburg, FL 
23 AGES 03 Nov - 05 Nov 2015 India Vadodara
24 USFDA 15 June - 18 June 2015 Canada Mississauga, Ontario
25 USFDA 23 Mar - 03 Apr 2015 India Ahmedabad Sigma
26 USFDA 03 Nov - 06 Nov 2014 Canada Mississauga, Ontario
27 USFDA 18 Aug - 22 Aug 2014 India Vadodara
28 Health Canada 21 July - 25 July 2014 Canada Mississauga, Ontario
29 USFDA 19 May - 23 May 2014 India Ahmedabad HQ
30 Health Canada  26  Mar 2014 Canada Mississauga, Ontario
31 USFDA 20 Jan - 24 Jan 2014 India Ahmedabad HQ
32 USFDA 24 Jun - 28 Jun 2013 India Vadodara
33 TURKEY MoH 09 Apr - 11 Apr 2013 India Ahmedabad HQ & Sigma
34 WHO 19 Mar - 22 Mar 2013 India Ahmedabad HQ & Vadodara
35 MHRA 25 Feb - 01 Mar 2013 India Ahmedabad HQ
36 WHO 19 Jun - 22 Jun 2012 India Ahmedabad HQ & Sigma
37 USFDA 03 Oct - 07 Oct 2011 India Vadodara
38 AEMPS 11 Apr - 15 Apr 2011 India Ahmedabad HQ & Vadodara
39 AGES 09 Feb - 10 Feb 2011 India Vadodara
40 USFDA 25 Oct - 27 Oct 2010 India Ahmedabad HQ
41 USFDA 18 Oct - 22 Oct 2010 India Ahmedabad Sigma
42 WHO 18 Oct - 20 Oct 2010 India Ahmedabad HQ
43 MCC 12 Jan - 13 Jan 2009 India Ahmedabad HQ
44 USFDA 15 Sept - 19 Sep 2008 India Vadodara
45 USFDA 20 Sept - 21 Sep 2007 India Ahmedabad HQ
46 USFDA 14 May - 17 May 2007 India Ahmedabad HQ
47 ANSM 6 Nov - 11 Nov 2006 India Ahmedabad HQ
48 USFDA 2011 USA Miamiville
49 USFDA 2011 USA St. Petersburg, FL 
50 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

Sr. No. Agency Inspection Date Country Location Specialty
1 USFDA 27 Jan – 31 Jan 20 India Belagavi   Dermatology
2 USFDA 15 Jan – 21 Jan 20 India Ahmedabad  Orthopedics
3 USFDA 18 Nov – 22 Nov – 19 India Mumbai  Orthopedics
4 USFDA 18 Nov – 22 Nov – 19 India Mumbai Dermatology
5 USFDA 18 Nov – 21 Nov – 19 India Ahmedabad  Orthopedics
6 USFDA 11 Nov – 15 Nov 19 India Vijayawada  Psychiatry
7 USFDA 11 Nov – 15 Nov 19 India Pune  Psychiatry
8 USFDA 04 Nov – 08 Nov 19 India Nashik  Dermatology
9 USFDA 04 Nov – 08 Nov 19 India Hubbali  Orthopedics
10 USFDA 04 Nov – 08 Nov 19 India Pune  Psychiatry
11 USFDA 21 Oct – 25 Oct 19 India Dombivli Dermatology
12 USFDA 14 Oct – 18 Oct 19 India Kanpur  Orthopedics
13 USFDA 11 Sep – 14 Sep 19 India Junagadh Psychiatry
14 USFDA 02 – 06 Sep 19 India Ahmedabad  Orthopedics
15 USFDA 13 – 20 Aug 19 India Ahmedabad  Dermatology
16 USFDA 13 – 20 Aug 19 India Ahmedabad  Orthopedics
17 USFDA 29 Jul – 02 Aug 19 India Ahmedabad  Psychiatry
18 USFDA 05-07 Mar 19 India Mumbai  Dermatology
19 USFDA 05-08 Feb 19 India Lucknow  Dermatology
20 USFDA 14-16 Nov 18 India Lucknow Dermatology
21 USFDA 17-20 Sep 18 India Himmatnagar  Orthopedics
22 USFDA 30 May – 01 Jun 18 India Pune Neurology
23 USFDA 28 May – 05 Jun 18 India Gandhinagar  Neurology
24 USFDA 11-13 Apr 18 India Goa  Oncology
25 USFDA 12-16 Mar 18 India Bangalore  Oncology
26 USFDA 16-18 Jan 18 USA Omaha, Nebraska Dermatology
27 USFDA 11-13 Dec 17 India Mumbai  Dermatology
28 USFDA 04-06 Dec 17 India Bangalore  Dermatology
29 USFDA 15-18 Nov 17 India Ahmedabad  Psychiatry
30 USFDA 20-24 Feb 17 India Pune Psychiatry
31 USFDA 23-26 Jan 17 India Junagadh  Psychiatry
32 USFDA 07-10 Nov 16 India Surat  Neurology
33 USFDA 15-19 Aug 16 India Pune  Neurology
34 USFDA 08-12 Aug 16 India Gandhinagar  Neurology
35 USFDA 25-28 Aug 14 India Vadodara Oncology
36 USFDA 28-31 Jul 14 India New Delhi Oncology
37 USFDA 24-27 Mar 14 India Madurai  Oncology
38 USFDA 24-27 Feb 14 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