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Regulatory History
|
YEAR
REGULATORY
|
2004 | 2005 | 2006 | 2007 | 2008 | 2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
DCGI
|
1 | 1 | 1 | 1 | 2 | 1 | 2 | 2 | 3 | 2 | 1 | |||||||||
|
USFDA
|
1 | 1 | 1 | 1 | 4 | 5 | 3 | 3 | 1 | 3 | 5 | 2 | 3 | 2 | 1 | 1 | 4 | 1 | ||
|
ANVISA
|
1 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 2 | 1 | 1 | |||||||||
|
WHO
|
3 | 5 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||||||||
|
EMA
|
1 | 1 | 2 | 1 | 1 | 2 | 2 | |||||||||||||
|
MCC - South Africa
 |
1 | 1 | ||||||||||||||||||
|
NPRA - Malaysia
 |
1 | 2 | ||||||||||||||||||
|
MoH - Thailand
 |
1 | |||||||||||||||||||
|
MoH - Turkey
 |
1 |
BA/BE Regulatory Approvals by Location
All our locations adhere to global regulatory standards
Ahmedabad
- DCGI
- US FDA
- WHO
- EMA
- ANVISA
Mumbai
- DCGI
- US FDA
- WHO
- EMA
- ANVISA
- NPRA-Malaysia
Vadodara
- DCGI
- US FDA
- WHO
Dr. Santosh Joshi
CEO
"Our company's regulatory department is the backbone of our operations. With unrivaled expertise, they navigate the ever-evolving landscape of compliance, ensuring our services adhere to all industry regulations. Their dedication enables us to deliver cutting-edge solutions with the highest standards of quality and safety, setting us apart as a trusted partner."
Clinical Data Services site approvals
| Sr. No | Regulatory Agency | Location | Therapeutic area | Inspection Timing |
|---|---|---|---|---|
| 1 | USFDA | Ahmedabad | Psychiatry | July 2012 |
| 2 | USFDA | Ahmedabad | Psychiatry | July 2012 |
| 3 | USFDA | Surat | Psychiatry | Sep 2015 |
| 4 | USFDA | Junagadh | Psychiatry | Apr 2015 |
| 5 | USFDA | Ahmedabad | Psychiatry | Jun 2018 |
| 6 | USFDA | Vijayawada | Oncology | Oct 2018 |
| 7 | USFDA | Surat | Oncology | Dec 2018 |
| 8 | USFDA | Vadodara | Oncology | Jan 2019 |
| 9 | USFDA | Bengaluru | Oncology | Jan 2020 |
| 10 | USFDA | Tamil Nadu | Oncology | Feb 2020 |
| 11 | NPRA | Junagadh | Psychiatry | Mar 2023* |
Biologics Regulatory Approvals
Our biologics facility has been granted DCGI approval with a validity period from September 2021 to September 2026.
Rest assured that we are fully committed to maintaining our high standards, and our facility is fully GCLP/GLP compliant.
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