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Bioanalysis

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Bioanalysis Services

Reliable, Accurate and On-Time

Compliance with GLP/GCLP Standards and Guidelines
  • GLP / GCLP Standards of MFDS, OECD, FDA
  • Bioanalysis Guidelines of MFDS, ICH, EMA, FDA
Service Scope
  • Method Development and Validation
  • PK Sample Analysis and Incurred Sample Reanalysis
  • Method Validation Report and Sample Analysis Report
List of Bioanalytical Methods
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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.

The analysis of BioInfra is reliable
  • In the 2012 Pre-Qualification Audit, WHO evaluated that BioInfra operates an infrastructure suitable for the bioanalytical method.
  • The GLP/GCLP reliability of BioInfra is constantly being checked through audits of licensing authorities and sponsors.
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)
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The analysis of BioInfra is outstanding in accuracy and reproducibility.

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%
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Reliable systems result in reliable data.
  • Qualified Person
  • Validated Method
  • Qualified Instruments
  • Certified Reagents and Materials
  • Controlled Environment
All tasks are carried out as per the document.
  • 192 SOPs and 274 Forms cover whole analytical processes
  • All plans are prepared in document for review and approval.
If it is not recorded it did not happen.
  • All tasks are recorded, inspected and reported.
  • The deviation in SOP and protocol is reported and supplemented by CAPA.
    SOP : Standard Operating Procedure
    CAPA : Corrective And Preventive Action
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