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ANALYTICAL METHOD VALIDATION


Kymanox supports pharmaceutical, biotechnology, medical device, and in vitro diagnostic device manufacturers in the validation of methods according to regulatory guidelines. We ensure phase-appropriate validation characteristics are clear for the intended application. The Kymanox Analytical Sciences group integrates Quality by Design (QbD), statistical Design of Experiment (DOE), and risk-based measures throughout the Analytical Method Validation lifecycle.


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Method Validation Support


Kymanox has expertise in multiple methods including, but not limited to, HPLC/UV, LC/MS, GC/MS, ELISA, PCR, FTIR, NMR, spectrophotometry, endotoxin, and sterility. We can support early and late-stage (e.g., development, Phase I, Phase II, Phase III/ Reg, Phase IV) method validation for New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and other global regulatory (ROW) submissions. With a comprehensive library of proven templates for protocols, study execution, and reports covering analytical techniques, we help minimize errors and review times to maximize effectiveness and efficiency.

Kymanox provides AMV support in the following areas:

    • Method Development, Optimization, and Transfer

    • Protocol and SOP Development and Execution

    • Document Review and Gap Assessments

    • Intended Use Establishment

    • Compliance Support for Assay Execution and Data Review

    • Product and Reference Standard Characterization

    • Cleaning Method and Process Alignment
    • Clear Strategy and Right First Time (RFT) Execution for Alternative Microbiological Methods

    Sample Guidance Expertise


    • ICH Q2(R1) Validation of Analytical Procedures

    • FDA Guidance for Industry: Analytical Procedures and Methods
      Validation for Drugs and Biologics

    • FDA Guidance for Industry: Bioanalytical Method Validation

    • PDA Technical Report No. 57, Analytical Method Validation and
      Transfer for Biotechnology Products

    • USP <1223> Validation of Alternative Microbiological Methods

    • USP <1210> Statistical Tools for Procedure Validation

    • ISO 5725: Accuracy (Trueness and Precision) of Measurement
      Methods and Results 

    Biotechnology | Pharmaceuticals | Medical Devices | Combination Products