Reliable, Accurate and On-Time
An analysis is to see things with the power of technology that cannot be seen with the naked eye.
The more precisely you see it, the safer and more useful it becomes.
Audit Date | Organization | Audit Type |
---|---|---|
2008 Oct | MFDS Korea | KGLP Regular, Biennial |
2009 Jan | MFDS Korea | BE Regular, Biennial |
2012 Aug | WHO(USP) | Pre-Qualification |
2012 Oct | Pfizer | Vendor/BE Study |
2014 Sep | Sanofi | Vendor/BE Study |
2016 Dec | Astellas | Pre-Qualification |
2019 Mar | MFDS Korea | KGCLP Regular, Biennial |
2019 Jun | Merck | Vendor Assessment |
2022 Nov | MFDS Korea | KGCLP Irregular (New Site) |
ISR Reproducibility of BioInfra far Surpassing
ICH Requirements
Total No of ISR Samples | Difference within ±10% | Difference within ±20% | |
---|---|---|---|
ICH Requirement | N.A. | N.A. | 67% |
BioInfra 2017 | 7,896 | 97.33% | 99.73% |
BioInfra 2018 | 8,233 | 97.33% | 99.83% |
BioInfra 2019 | 17,674 | 97.85% | 99.74% |
BioInfra 2020 | 18,164 | 97.95% | 99.66% |
BioInfra 2021 | 24,935 | 98.00% | 99.90% |
BioInfra 2022 | 29,052 | 98.25% | 99.81% |