Analytical Method Robustness, Qualification and Validation

Delivering regulatory ready methods

We design and execute robustness, qualification, and validation studies that prove analytical methods are reliable, reproducible, and fit for their intended use. Our approach blends practical lab experience with rigorous statistical design, so your assays survive scale‑up, inspection, and real‑world use.

Method Robustness

  • Small changes in reagents, incubation times, or equipment can derail an assay during transfer or scale‑up. Robustness studies identify which parameters matter and define safe operating ranges before problems arise.

    • Critical parameter identification using risk assessment and prior‑knowledge review.

    • DOE‑driven study design (fractional factorial, Plackett‑Burman, or full factorial) to evaluate multiple factors efficiently.

    • Quantitative impact analysis to measure effect sizes, interactions, and tolerance limits.

    • Actionable controls: recommended setpoints, in‑process checks, and acceptance limits to reduce failure modes.

    • Reduce troubleshooting time during scale‑up and transfer.

    • Minimize batch failures and rework.

    • Create defensible operating ranges for regulatory submissions.

    • DOE matrix and study plan outlining factors, levels, and randomization.

    • Tolerance limits and operating ranges for critical parameters.

    • Risk assessment summary linking failure modes to controls.

    • Actionable control recommendations (setpoints, in‑process checks, acceptance limits).

    • Executive summary with key findings and recommended next steps

Method Qualification

  • Qualification demonstrates a method is fit for a specific development stage or internal decision point. It’s the practical bridge between early development and full validation.

  • What we do

    • Fit‑for‑purpose protocols tailored to identity, potency, functional, or safety assays.

    • Study execution options: We can draft a protocol for your QC lab to run, perform studies side‑by‑side with your team, or execute them at our facility.

    • Defined acceptance criteria for precision, accuracy, linearity, and system suitability.

    • Comprehensive reporting: raw data, statistical analysis, deviations, and recommendations.

    • Faster go/no‑go decisions with documented evidence.

    • Clear handoffs to validation or routine QC.testing

    • Reduced risk when moving from R&D to regulated testing.

    • Fit‑for‑purpose qualification protocol with objectives and acceptance criteria.

    • Technical summary report with pass/fail determinations and interpretation.

    • Defined acceptance criteria document for the specific development stage.

    • Handoff package summarizing readiness for validation or routine QC testing.

Method Validation

  • Validation provides the documented proof regulators and stakeholders expect: the method performs accurately and reliably for release, stability, or comparability testing.

    • Regulatory‑aligned validation plans based on ICH Q2(R2) and applicable guidance.

    • Full validation execution: specificity, linearity, accuracy, precision, LOD/LOQ, robustness, and stability.

    • On‑site support: guidance for your QC team, or turnkey execution by our scientists.

    • Regulatory‑ready documentation for submissions and inspections.

    • Confidence that release and stability testing will stand up to scrutiny.

    • Shorter timelines and fewer iterations during regulatory review

    • Regulatory aligned validation plan (ICH Q2(R2) mapping and decision rules).

    • Full validation protocol and execution records for all parameters.

    • Comprehensive validation report with conclusions and regulatory statements.

    • Complete raw data package and statistical analyses (regression, ANOVA, LOD/LOQ).

    • SOP updates and QC checklists reflecting validated controls.