Regulatory Inspections & Approvals
A proven history of successful inspections by leading global health authorities, demonstrating our commitment to compliance, quality & integrity
Synergen Bio has consistently met the rigorous standards of international regulatory agencies. Our facilities have undergone multiple inspections and approvals, establishing us as a trusted CRO partner for global submissions.
March 2025
USFDA
Jan 2025
USFDA
Jan 2025
CDSCO
Approval for Phase-1 Unit
Apr 2024
EMA
(BfArM and DKMA)
Mar 2023
USFDA
Oct 2022
ISP Chile
Dec 2021
CDSCO
(Facility extension for additional 60 beds)
Jul 2021
USFDA
Dec 2020
ISP Chile
Nov 2020
CDSCO
(Facility extension for additional 56 Beds)
Jun 2019
CDSCO
First time for 44 Beds.
Commitment to Compliance
We maintain inspection readiness at all times through continuous staff training, robust SOPs, and internal QA audits.
Every successful inspection underscores our commitment to quality, transparency, and regulatory integrity in all aspects of clinical and bioanalytical research.