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 18 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 07 Nov - 10 Nov 2022 Canada Mississauga, Ontario
2 NPRA 03 Oct – 07 Oct 2022 India Cliantha Corporate
3 USFDA 04 Jul - 08 Jul 2022 India Vadodara
4 ANVISA 16 May - 20 May 2022 India Ahmedabad Cliantha Corporate
5 USFDA 15 Nov - 19 Nov 2021 India Ahmedabad Cliantha Corporate
6 MHRA 07 Jun - 16 Jun 2021 India Ahmedabad
7 USFDA 19 Apr - 23 Apr 2021 India Noida
8 USFDA 19 Jan- 29 Jan 2021 USA Petersburg.FL
9 USFDA 02 Dec - 06 Dec 2019 India Ahmedabad (Sigma)
10 USFDA 16 Jul -19 Jul 2019 India Ahmedabad (HQ)
11 USFDA 15 Jul -19 Jul 2019 India Vadodara
12 USFDA 24 Jun -28 Jun 2019 USA St. Petersburg, FL site
13 USFDA 29 Oct - 2 Nov 2018 Canada Mississauga, Ontario
14 USFDA 25 Jul - 31 July 2018 USA New Jersey
15 WHO 25 Jun - 29 Jun 2018 India Ahmedabad HQ & Sigma
16 USFDA 05 Mar - 09 Mar 2018 India Noida
17 AEMPS 28 Jun - 30 Jun 2017 Canada Mississauga, Ontario
18 USFDA 03 May - 15 May 2017 USA St. Petersburg, FL 
19 MHRA 24 Apr - 28 Apr 2017 India Ahmedabad HQ & Sigma
20 Health Canada 18 Apr - 19 Apr 2017 Canada Mississauga, Ontario
21 USFDA 20 Mar - 23 Mar 2017 India Ahmedabad HQ
22 USFDA 14 Mar - 17 Mar 2017 India Ahmedabad Sigma
23 DEA 22 Feb - 01 Mar 2017 USA St. Petersburg.FL
24 USFDA 28 Nov - 02 Dec 2016 India Vadodara
25 USFDA 14 Nov - 17 Nov 2016 Canada Mississauga, Ontario
26 Health Canada 21 Mar - 28 Mar 2016 Canada Mississauga, Ontario
27 USFDA 14 Mar - 17 Mar 2016 Canada Mississauga, Ontario
28 USFDA 19 Jan – 19 Feb 2016 USA St. Petersburg, FL 
29 USFDA 18 Jan - 22 Jan 2016 India Ahmedabad HQ
30 USFDA 11 Jan - 19 Jan 2016 USA St. Petersburg, FL 
31 AGES 03 Nov - 05 Nov 2015 India Vadodara
32 USFDA 15 June - 18 June 2015 Canada Mississauga, Ontario
33 USFDA 23 Mar - 03 Apr 2015 India Ahmedabad Sigma
34 USFDA 03 Nov - 06 Nov 2014 Canada Mississauga, Ontario
35 USFDA 18 Aug - 22 Aug 2014 India Vadodara
36 Health Canada 21 July - 25 July 2014 Canada Mississauga, Ontario
37 USFDA 19 May - 23 May 2014 India Ahmedabad HQ
38 Health Canada  26  Mar 2014 Canada Mississauga, Ontario
39 USFDA 20 Jan - 24 Jan 2014 India Ahmedabad HQ
40 USFDA 24 Jun - 28 Jun 2013 India Vadodara
41 TURKEY MoH 09 Apr - 11 Apr 2013 India Ahmedabad HQ & Sigma
42 WHO 19 Mar - 22 Mar 2013 India Ahmedabad HQ & Vadodara
43 MHRA 25 Feb - 01 Mar 2013 India Ahmedabad HQ
44 WHO 19 Jun - 22 Jun 2012 India Ahmedabad HQ & Sigma
45 USFDA 03 Oct - 07 Oct 2011 India Vadodara
46 AEMPS 11 Apr - 15 Apr 2011 India Ahmedabad HQ & Vadodara
47 AGES 09 Feb - 10 Feb 2011 India Vadodara
48 USFDA 25 Oct - 27 Oct 2010 India Ahmedabad HQ
49 USFDA 18 Oct - 22 Oct 2010 India Ahmedabad Sigma
50 WHO 18 Oct - 20 Oct 2010 India Ahmedabad HQ
51 MCC 12 Jan - 13 Jan 2009 India Ahmedabad HQ
52 USFDA 15 Sept - 19 Sep 2008 India Vadodara
53 USFDA 20 Sept - 21 Sep 2007 India Ahmedabad HQ
54 USFDA 14 May - 17 May 2007 India Ahmedabad HQ
55 ANSM 6 Nov - 11 Nov 2006 India Ahmedabad HQ
56 USFDA 2011 USA Miamiville
57 USFDA 2011 USA St. Petersburg, FL 
58 USFDA 2011 USA Miamiville

Bioanalytical

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

Multicentric Sites

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

Clinical Lab

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