Accuracy And Precision, Within And Between Runs
- Multiple QC levels across multiple runs, with 15% criteria and 20% at the LLOQ stated
- The core table an auditor reads first, generated the same way on LC-MS and ligand binding
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De-Risk Your Method Validation, ICH M10 and FDA.
Brief PhDs on your method, use and timeline.- Full Validation In Three-Day LC-MS/MS Or Six-Day ELISA Runs, Documented End To End
- Accuracy, Precision, Selectivity, Stability And Carryover With Stated Acceptance
- Fit-For-Purpose, GLP And GCLP Validation Tiers Matched To What The Data Must Defend
- Incurred Sample Reanalysis Designed Into The Validation Plan, Never Bolted On After
Regulated And Inspected By:
What A Validation At Our Lab Actually Measures
The work is a defined set of experiments covering six parameter families, with acceptance limits stated in a plan your QA reviews first.
Selectivity, Specificity And Matrix Effects
- Interference screened in the real matrix, hemolyzed and lipemic where the study needs it
- Ligand binding adds parallelism and MRD; chromatography adds recovery and ion effects
Sensitivity, Range And Response: LLOQ To ULOQ
- The LLOQ proven against blank response, calibration model fit and range locked to use
- No reported number ever comes from outside the validated range, which is the whole point
Carryover, Dilution Integrity And Reinjection
- The unglamorous parameters that fail audits, tested and documented before samples run
- Dilution schemes proven for above-range samples, reinjection reproducibility on record
Stability, Every Way Your Samples Will Live
- Benchtop, freeze-thaw, autosampler, extracted and long-term storage stability documented
- Stability windows sized to your study design, so trial logistics never outrun the data
Incurred Sample Reanalysis, Designed In Early
- A defined fraction of study samples reanalyzed to prove the method on real specimens
- Written into the validation plan and budget from day one, never negotiated post-finding
The Validation Ladder: Fit-For-Purpose, Full, Partial, Cross, Revalidation
Fit-for-purpose, full GLP, partial, cross, revalidation. A new instrument, reagent lot or analyst triggers a scoped revalidation, not a new engagement.
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Fit-For-Purpose Qualification
Discovery and exploratory work: the method proven for its context of use, documented lean
Non-GLP Testing -
Full Validation, GLP Or GCLP
The complete parameter set above, for data that faces FDA, run under Part 58 or GCLP
GLP Laboratory -
Partial Validation
A validated method changed in matrix, species, range or anticoagulant revalidates only what moved
Bioanalytical Assay -
Cross-Validation
Two labs or two methods on the same analyte proven equivalent with shared samples
Method Transfer -
Revalidation After Change
New instrument, new critical reagent lot or new analyst triggers a scoped revalidation
Facility & Equipment -
The Method Before All Of This
A method that validates cleanly was developed with validation in mind, one page over
Method Development
Ready To Start? Scope Your Method Validation.
Tailored validation quote in 2 days.
Failing Validation Costs You Twice, So Ours Are Designed To Pass
Trouble comes from acceptance limits fixed late, stability gaps and matrix surprises. Our plan closes all three before any sample is run.
Talk Science First? Ask Our Validation Experts.
Discuss ICH M10, tier and intended use.- Full validation runs two to three weeks on LC-MS/MS and four to six on ligand binding, as three-day and six-day run designs with the report following, so your submission date holds.
- The plan states every acceptance criterion before the first run, so validation is a checklist executed on schedule rather than a negotiation conducted after a parameter goes sideways.
- Methods arriving from our own development bench validate cleanly because they were built to these criteria from day one, and more than 90% of them go on to run study samples here.
500+Custom Methods Developed, Validated And Run In House
3-6Day Validation Run Designs On LC-MS/MS And ELISA
What Does Method Validation Cost?
Scope drives price: the parameter set, the number of runs and the tier are itemized in the quote rather than flattened into a day rate. Full validation runs two to three weeks on LC-MS/MS and four to six on ligand binding, partial validation costs a fraction of full, and a senior scientist replies within two business days.
Your Cost Cannot Move Mid-Study
The quote you approve is the price you pay. Cost cannot move mid-study without an SOW addendum you have already approved, which matters when validation gates a submission date that will not move for anyone.
Sponsors Whose Methods Went Through Audit With Us
A validation that holds up under review earns the next assignment, which is how more than 90% of methods developed in our lab go on to run study samples with us.
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VP, PK PD Analysis
NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.
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Executive, Clinical Stage Biotech
There was an issue with half-life extrapolation, and NorthEast BioLab brought in the right experts to find the solution.
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Executive Director, Drug Research
NorthEast BioLab provides critical insight, and are compliant with regulatory standards and industry best practices. We highly recommend them and look forward to working together again.
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Head, PK
This study, same as all other bioanalytical studies, was completed with top quality and reporting standard with incredible responsiveness.
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VP, Clinical Stage Biotech
The ability to work with our timelines to meet deadlines is very much appreciated.
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VP, Bioanalytical Development
NorthEast BioLab is the most responsive and thorough bioanalysis lab services CRO.
Full or Partial Validation? Tell Us Your Submission.
Share the method and intended use. We'll set the tier.Why QA Teams Sign Off On Methods We Validated
We bring two decades of submission-ready validations, on a fleet where a sibling instrument is already qualified when yours needs maintenance.
What You Receive
- A validation plan with every parameter and acceptance criterion stated before run one
- The validation report that your IND, NDA or BLA cites, QA reviewed under GLP or GCLP
- ISR results inside the package, so the inspector’s favorite question is pre-answered
- A method your program keeps: partial validation covers changes instead of restarts
What We Need From You
- The method file if one exists, or the development hand-off if we built it next door
- Reference standard and critical reagents with certificates, sized to the run design
- Your regulatory context, IND, NDA or ANDA, because it decides the validation scope
- The study design behind it, so stability arms and ISR sizing match how samples live
Comprehensive Guide to ELISA Assay Validation: Best Practices & Key Insights
The enzyme-linked immunosorbent assay (ELISA) is a robust analytical immunochemistry method based on specific antigen-antibody interactions. The application of ELISA in clinical and biomedical research has significantly altered the practice of bioanalytical laboratories….
One Full GLP Validation, Plan To Report: A Representative Run, Step By Step
Parameters are fixed up front and runs execute against pre-stated acceptance criteria, with QAU checks at every turn. Nothing is improvised or decided after the fact.
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1. Validation Plan Signed
Parameters, runs and acceptance criteria fixed, QAU reviewed
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2. Runs Executed
Three-day LC-MS/MS or six-day ELISA validation batches on the fleet
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3. Stability Suite
Benchtop, freeze-thaw, autosampler and storage arms read out
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4. Criteria Met
Accuracy, precision, selectivity and carryover against stated limits
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5. ISR Scheduled
Incurred sample reanalysis set against the first study batches
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6. Audited Report Out
The validation report your submission cites, QA reviewed and signed
Why Do Sponsors Choose Our Lab To Validate Their Methods?
Because the validation plan is written to ICH M10 and signed before execution, so passing is engineering rather than luck.
Get Your Validation Plan Reviewed By PhD Scientists.
Send your plan. We'll flag pitfalls before they cost you.- Validations to FDA guidance and ICH M10 with five FDA inspections behind the SOPs
- Three-day LC-MS/MS and six-day ELISA run designs, so the calendar is a design choice
- 500+ custom methods with more than 90% carrying forward into study sample analysis
- Partial, cross and revalidation handled as scoped steps, never as fresh engagements
Regulated And Inspected By:
Validation Built To Be Cited In Your Submission
Send the method file or molecule plus regulatory context, and a plan outline with a quote returns, scoped to the platforms linked below.
Related FAQs
What sponsors ask before committing a method to validation, answered.
What's the difference between assay qualification and validation?
What experiments are included in validation?
How many validation runs are done and what do they measure?
What stability tests are performed?
What documentation is provided for FDA and ICH submissions?
What is partial validation?
Can you use previously validated methods for new projects?
When is re-validation of a method necessary?
Which guidance do you validate against?
What are the actual acceptance criteria?
How long does a full validation take?
What is ISR and will we need it?
Can you validate a method another lab developed?
What if the method fails a parameter?
Explore More Solutions
A validated method is meant to be used, and our pharmacokinetics and biomarker teams put it to work on your study.
