Regulatory

Meeting the legal directives across global regulatory environments and keeping up to date with changes is one of the key aspects in clinical research.

At Cliantha, our team has expertise in assessing emerging regulatory trends, developing advocacy strategies, and defining process improvement that facilitates drug approval & registration process. Some of the key regulators, such as the USFDA, EMA, AGES, ANSM, AMPS, MCC South Africa, Health Canada, DCGI, CAP, NABL, Turkey MOH, Thailand MoPH and Malaysia NPRA have successfully inspected Cliantha across the globe. With 19 Years of extensive experience in clinical research, we share best practices, expertise, and learnings to enable superior services and results to our sponsors.

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

Clinic

Sr. No Agency Inspection Date Country Location
1 USFDA 08 Apr - 12 Apr 2024 India Vadodara
2 USFDA 01 Apr - 05 Apr 2024 India Ahmedabad
3 WHO 30 Nov - 01 Dec 2023 India Ahmedabad
4 USFDA 30 Oct - 03 Nov 2023 India Noida
5 AEMPS 25 Jul - 28 Jul 2023 India Vadodara
6 USFDA 07 Nov - 10 Nov 2022 Canada Mississauga, Ontario
7 NPRA 03 Oct – 07 Oct 2022 India Cliantha Corporate
8 USFDA 04 Jul - 08 Jul 2022 India Vadodara
9 ANVISA 16 May - 20 May 2022 India Ahmedabad Cliantha Corporate
10 USFDA 15 Nov - 19 Nov 2021 India Ahmedabad Cliantha Corporate
11 MHRA 07 Jun - 16 Jun 2021 India Ahmedabad
12 USFDA 19 Apr - 23 Apr 2021 India Noida
13 USFDA 19 Jan- 29 Jan 2021 USA Petersburg.FL
14 USFDA 02 Dec - 06 Dec 2019 India Ahmedabad (Sigma)
15 USFDA 16 Jul -19 Jul 2019 India Ahmedabad (HQ)
16 USFDA 15 Jul -19 Jul 2019 India Vadodara
17 USFDA 24 Jun -28 Jun 2019 USA St. Petersburg, FL site
18 USFDA 29 Oct - 2 Nov 2018 Canada Mississauga, Ontario
19 USFDA 25 Jul - 31 July 2018 USA New Jersey
20 WHO 25 Jun - 29 Jun 2018 India Ahmedabad HQ & Sigma
21 USFDA 05 Mar - 09 Mar 2018 India Noida
22 AEMPS 28 Jun - 30 Jun 2017 Canada Mississauga, Ontario
23 USFDA 03 May - 15 May 2017 USA St. Petersburg, FL 
24 MHRA 24 Apr - 28 Apr 2017 India Ahmedabad HQ & Sigma
25 Health Canada 18 Apr - 19 Apr 2017 Canada Mississauga, Ontario
26 USFDA 20 Mar - 23 Mar 2017 India Ahmedabad HQ
27 USFDA 14 Mar - 17 Mar 2017 India Ahmedabad Sigma
28 DEA 22 Feb - 01 Mar 2017 USA St. Petersburg.FL
28 USFDA 28 Nov - 02 Dec 2016 India Vadodara
30 USFDA 14 Nov - 17 Nov 2016 Canada Mississauga, Ontario
31 Health Canada 21 Mar - 28 Mar 2016 Canada Mississauga, Ontario
32 USFDA 14 Mar - 17 Mar 2016 Canada Mississauga, Ontario
33 USFDA 19 Jan – 19 Feb 2016 USA St. Petersburg, FL 
34 USFDA 18 Jan - 22 Jan 2016 India Ahmedabad HQ
35 USFDA 11 Jan - 19 Jan 2016 USA St. Petersburg, FL 
36 AGES 03 Nov - 05 Nov 2015 India Vadodara
37 USFDA 15 June - 18 June 2015 Canada Mississauga, Ontario
38 USFDA 23 Mar - 03 Apr 2015 India Ahmedabad Sigma
39 USFDA 03 Nov - 06 Nov 2014 Canada Mississauga, Ontario
40 USFDA 18 Aug - 22 Aug 2014 India Vadodara
41 Health Canada 21 July - 25 July 2014 Canada Mississauga, Ontario
42 USFDA 19 May - 23 May 2014 India Ahmedabad HQ
43 Health Canada  26  Mar 2014 Canada Mississauga, Ontario
44 USFDA 20 Jan - 24 Jan 2014 India Ahmedabad HQ
45 USFDA 24 Jun - 28 Jun 2013 India Vadodara
46 TURKEY MoH 09 Apr - 11 Apr 2013 India Ahmedabad HQ & Sigma
47 WHO 19 Mar - 22 Mar 2013 India Ahmedabad HQ & Vadodara
48 MHRA 25 Feb - 01 Mar 2013 India Ahmedabad HQ
49 WHO 19 Jun - 22 Jun 2012 India Ahmedabad HQ & Sigma
50 USFDA 03 Oct - 07 Oct 2011 India Vadodara
51 AEMPS 11 Apr - 15 Apr 2011 India Ahmedabad HQ & Vadodara
52 AGES 09 Feb - 10 Feb 2011 India Vadodara
53 USFDA 25 Oct - 27 Oct 2010 India Ahmedabad HQ
54 USFDA 18 Oct - 22 Oct 2010 India Ahmedabad Sigma
55 WHO 18 Oct - 20 Oct 2010 India Ahmedabad HQ
56 MCC 12 Jan - 13 Jan 2009 India Ahmedabad HQ
57 USFDA 15 Sept - 19 Sep 2008 India Vadodara
58 USFDA 20 Sept - 21 Sep 2007 India Ahmedabad HQ
59 USFDA 14 May - 17 May 2007 India Ahmedabad HQ
60 ANSM 6 Nov - 11 Nov 2006 India Ahmedabad HQ
61 USFDA 2011 USA Miamiville
62 USFDA 2011 USA St. Petersburg, FL 
63 USFDA 2011 USA Miamiville

Bioanalytical

Sr. No Agency Inspection Date Country Location
1 USFDA 27 May - 31 May 2024 India Ahmedabad Cliantha Corporate
2 WHO 30 Nov - 01 Dec 2023 India Ahmedabad
3 AEMPS 31 Jul - 04 Aug 2023 India Ahmedabad Cliantha Corporate
4 USFDA 20 Mar – 24 Mar 2023 Canada Toronto, Ontario
5 NPRA 03 Oct – 07 Oct 2022 India Cliantha Corporate
6 ANVISA 16 May - 20 May 2022 India Ahmedabad Cliantha Corporate
7 USFDA 08 Nov - 12 Nov 2021 India Ahmedabad Cliantha Corporate & Ahmedabad HQ
8 MHRA 07 Jun - 16 Jun 2021 India Ahmedabad
9 USFDA 12 Aug - 16 Aug 2019 Canada Toronto, Ontario
10 USFDA 30 Jul - 03 Aug 2018 India Ahmedabad HQ & Sigma
11 WHO 25 Jun - 29 Jun 2018 India Ahmedabad HQ & Sigma
12 AEMPS 16 Nov - 20 Nov 2017 Canada Toronto, Ontario
13 Health Canada 15 Jun 2017 Canada Toronto, Ontario
14 USFDA 15 May - 19 May 2017 Canada Toronto, Ontario
15 MHRA 24 Apr - 28 Apr 2017 India Ahmedabad HQ & Sigma
16 Health Canada 27 Apr - 28 Apr 2016 Canada Toronto, Ontario
17 USFDA 25 Apr - 03 May 2016 India Ahmedabad HQ
18 Health Canada 02 Mar 2016 Canada Toronto, Ontario
19 USFDA 19 May - 23 May 2014 India Ahmedabad HQ
20 THAILAND MoPH 15 July - 18 Jul 2013 India Ahmedabad HQ
21 TURKEY MoH 09 Apr - 11 Apr 2013 India Ahmedabad HQ & Sigma
22 WHO 19 Mar - 22 Mar 2013 India Ahmedabad HQ & Vadodara
23 MHRA 25 Feb - 01 Mar 2013 India Ahmedabad HQ
24 WHO 19 Jun - 22 Jun 2012 India Ahmedabad HQ & Sigma
25 AEMPS 11 Apr - 15 Apr 2011 India Ahmedabad HQ
26 WHO 18 Oct - 20 Oct 2010 India Ahmedabad HQ
27 USFDA 17 Jun - 23 Jun 2010 India Ahmedabad HQ
28 MCC 12 Jan - 13 Jan 2009 India Ahmedabad HQ
29 USFDA 20 Sept - 21 Sep 2007 India Ahmedabad HQ
30 ANSM 6 Nov - 11 Nov 2006 India Ahmedabad HQ

Multicentric Sites

Sr. No. Agency Inspection Date Country Location Specialty
1 USFDA 20 May - 24 May 2024 India Vijaywada Psychiatry
2 USFDA 14 May - 17 May 2024 India Hydrabad Psychiatry
3 USFDA 18 Mar - 22 Mar 2024 India Bhavnagar Dermatology
4 USFDA 11 Mar - 15 Mar 2024 India Ahmedabad Dermatology
5 USFDA 04 Mar - 08 Mar 2024 India Nagpur Dermatology
6 USFDA 15 Jan - 19 Jan 2024 India Ahmedabad Dermatology
7 USFDA 04 Jan - 09 Jan 2024 India Gurugram Dermatology
8 USFDA 28 Dec - 30 Dec 2023 India Bangalore Dermatology
9 USFDA 04 Dec - 06 Dec 2023 India Ahmedabad Dermatology
10 USFDA 06 Nov – 09 Nov 2023 India Surat Dermatology
11 USFDA 30 Oct – 01 Nov 2023 India Nagpur Dermatology
12 USFDA 11 Sep - 15 Sep 2023 India Gandhinagar Respiratory
13 USFDA 07 Sep - 13 Sep 2023 India Vadodara Respiratory
14 USFDA 17 Apr - 21 Apr 2023 India Bikaner Oncology
15 USFDA 06 Mar - 10 Mar 2023 India Nashik Oncology
16 USFDA 06 Feb – 10 Feb 2023 India Pune Oncology
17 USFDA 12 Dec - 15 Dec 2022 India Ahmedabad Orthopedics
18 USFDA 5 Dec - 8 Dec 2022 India Ahmedabad Orthopedics
19 USFDA 25 Apr - 29 Apr 2022 India Kozhikode Psychiatry
20 USFDA 19 Apr - 22 Apr 2022 India Mysuru Psychiatry
21 USFDA 20 Jan - 11 Mar 2021 India Pune Dermatology
22 USFDA 08 Jan - 08 Mar 2021 India Varanasi Dermatology
23 USFDA 18 Dec - 21 Jan 2021 India Hyderabad Psychiatry
24 USFDA 27 Jan - 31 Jan 2020 India Belagavi   Dermatology
25 USFDA 15 Jan - 21 Jan 2020 India Ahmedabad  Orthopedics
26 USFDA 18 Nov - 22 Nov 2019 India Mumbai  Orthopedics
27 USFDA 18 Nov - 22 Nov 2019 India Mumbai Dermatology
28 USFDA 18 Nov - 21 Nov 2019 India Ahmedabad  Orthopedics
29 USFDA 11 Nov - 15 Nov 2019 India Vijayawada  Psychiatry
30 USFDA 11 Nov - 15 Nov 2019 India Pune  Psychiatry
31 USFDA 04 Nov - 08 Nov 2019 India Nashik  Dermatology
32 USFDA 04 Nov - 08 Nov 2019 India Hubbali  Orthopedics
33 USFDA 04 Nov - 08 Nov 2019 India Pune  Psychiatry
34 USFDA 21 Oct - 25 Oct 2019 India Dombivli Dermatology
35 USFDA 14 Oct - 18 Oct 2019 India Kanpur  Orthopedics
36 USFDA 11 Sep - 14 Sep 2019 India Junagadh Psychiatry
37 USFDA 02 Sep - 06 Sep 2019 India Ahmedabad  Orthopedics
38 USFDA 13 Aug - 20 Aug 2019 India Ahmedabad  Dermatology
39 USFDA 13 Aug - 20 Aug 2019 India Ahmedabad  Orthopedics
40 USFDA 29 Jul - 02 Aug 2019 India Ahmedabad  Psychiatry
41 USFDA 05 Mar - 07 Mar 2019 India Mumbai  Dermatology
42 USFDA 05 Feb - 08 Feb 2019 India Lucknow  Dermatology
43 USFDA 14 Nov - 16 Nov 2018 India Lucknow Dermatology
44 USFDA 17 Sep - 20 Sep 2018 India Himmatnagar  Orthopedics
45 USFDA 30 May - 01 Jun 2018 India Pune Neurology
46 USFDA 28 May - 05 Jun 2018 India Gandhinagar  Neurology
47 USFDA 11 Apr -13 Apr 2018 India Goa  Oncology
48 USFDA 12 Mar - 16 Mar 2018 India Bangalore  Oncology
49 USFDA 16 Jan - 18 Jan 2018 USA Omaha, Nebraska Dermatology
50 USFDA 11 Dec - 13 Dec 2017 India Mumbai  Dermatology
51 USFDA 04 Dec - 06 Dec 2017 India Bangalore  Dermatology
52 USFDA 15 Nov - 18 Nov 2017 India Ahmedabad  Psychiatry
53 USFDA 20 Feb - 24 Feb 2017 India Pune Psychiatry
54 USFDA 23 Jan - 26 Jan 2017 India Junagadh  Psychiatry
55 USFDA 07 Nov - 10 Nov 2016 India Surat  Neurology
56 USFDA 15 Aug - 19 Aug 2016 India Pune  Neurology
57 USFDA 08 Aug - 12 Aug 2016 India Gandhinagar  Neurology
58 USFDA 25 Aug - 28 Aug 2014 India Vadodara Oncology
59 USFDA 28 Jul - 31 Jul 2014 India New Delhi Oncology
60 USFDA 24 Mar - 27 Mar 2014 India Madurai  Oncology
61 USFDA 24 Feb - 27 Feb 2014 India Nagpur  Oncology

Clinical Lab

Sr. No Regulatory Agency Inspection Country Location
1 CAP Jan-24 India Noida
2 CAP Aug-23 India Ahmedabad Cliantha Corporate & Vadodara
3 NABL Jun-23 India Ahmedabad Cliantha Corporate
4 NABL Jul-22 India Ahmedabad Cliantha Corporate
5 CAP Apr-22 India Ahmedabad Cliantha Corporate, Vadodara & Noida (Property 2A)
6 NABL Aug-21 India Ahmedabad Cliantha Corporate
7 CAP Nov-19 India Noida
8 CAP Sep-19 India Ahmedabad Sigma & Vadodara
9 NABL Feb-19 India Ahmedabad Sigma
10 CAP Jan-18 India Noida
11 NABL Oct-17 India Ahmedabad Sigma
12 CAP Sep-17 India Ahmedabad Sigma & Vadodara
13 NABL Oct-16 India Ahmedabad Sigma
14 CAP Sep-15 India Ahmedabad Sigma & Vadodara
15 CAP Sep-13 India Ahmedabad Sigma & Vadodara
16 NABL Aug-13 India Ahmedabad Sigma
17 ANVISA Jul-12 India Ahmedabad Sigma
18 CAP Aug-11 India Ahmedabad Sigma & Vadodara
19 CAP Sep-10 India Vadodara
20 CAP Sep-09 India Ahmedabad Sigma
21 CAP Sep-08 India Vadodara
22 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

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