Signature to results in two to four weeks for small and mid sized projects, with batches accepted as they exist. Method adaptation from the validated library often takes days, and the quote carries dates you can hold us to.

Non-GLP Bioanalysis for Preclinical PK/TK & Biomarkers

Q: What exactly do we give up by going non-GLP?

The Part 58 formalities: a named study director, the QAU audit of the study, and incurred sample reanalysis. You keep the instruments, the scientists, a documented method and stated acceptance criteria. If your data will face an FDA reviewer, you need GLP, and we will say so in the quote rather than sell you the cheaper tier.

Q: Is the data still trustworthy without GLP?

It runs on the same twelve LC-MS systems and immunoassay platforms as our regulated studies, by the same people, with methods documented and criteria stated. Non-GLP here means lighter paperwork, not looser science.

Q: Can the work upgrade to GLP later?

That is the design intent. Methods are written as if validation is coming, so tightening to GLP validation is a planned step with the record intact, and the validation page explains what that step includes.

Q: Do you test non-pharmaceutical products under this page?

Consumer and personal care product questions have their own page, Personal Care Testing, with the same instrument discipline pointed at actives, preservatives, claims and stability. This page is the research tier for drug programs.

Q: When should we not use non-GLP?

Pivotal safety studies filing into an IND, clinical sample analysis, and any data an agency will read: those need GLP or GCLP, and the GLP Laboratory page is the right door. The wrong tier in either direction wastes money, which is why the quote names the tier first.

De-Risk Your Non-GLP PK and TK Bioanalysis, Fast.

Brief PhDs on your molecule, species and study.

Research Tier PK, TK, Immunogenicity And PD Screening Without GLP Documentation
The Same Twelve LC-MS, Immunoassay And PCR Fleet That Runs Our Regulated Studies
Two To Four Weeks From Signature To Results, With No Minimum Batch Size To Commit
Methods Documented For The Upgrade, So Non-GLP Today Never Means Restarting Later

Regulated And Inspected By:

What Non-GLP Buys You, And What It Honestly Gives Up

You keep the instruments, the scientists and a documented method; you give up the study director formality, the QAU audit and ISR. That is exactly why it costs less and moves faster.

Discovery PK And Exposure At The Research Tier

Plasma, tissue and CSF exposures by LC-MS/MS for pilot studies and lead ranking decisions
Cassette style efficiency where the science allows, single analyte rigor where it counts

Dose Range Finding And Non-GLP TK Study Support

Exposure confirmation behind DRF and pilot tox, cohort by cohort to the in-life calendar
The rehearsal for the GLP study, run on the instruments the GLP study will actually use

Immunogenicity And PD Biomarker Screening Panels

ADA screening and PD biomarker panels at research rigor, run on MSD, Luminex and ELISA
The very same platforms your clinical tiers will use later, so nothing rebases downstream

Fit-For-Purpose Methods, Adapted Or Built In Days

Existing methods adapted or lean methods built, scoped in the quote with what they include
Documented like validation is coming, because for most successful programs it eventually is

Cell-Based And Biochemical Research Screens

Potency, viability and binding screens ranked reproducibly with stated plate controls
IC50 series and affinity ranking that hold up when a development team reruns the work

The Upgrade Path, Priced Before You Need It

Tightening to GLP validation is a planned step here, never a restart at a second lab
The quote can show both tiers side by side, so the later decision is already budgeted

What The Research Tier Drops, And What It Keeps

Built for rank-order and go or no-go decisions, where full validation would buy rigor the question does not need.

Drops The QAU Audit

No independent quality unit pass, because exploratory data does not face an agency
Drops Full Validation

A lean fit-for-purpose method with stated scope instead of the complete parameter set
Method Validation
Drops The GLP Paper Load

Protocol amendments and audit trails shrink to what the decision actually needs
Keeps The Instruments

The same qualified LC-MS fleet the GLP studies run on, not a second-tier bench
Keeps The Scientists

The same senior people, so the method can graduate later with its history intact
Keeps Stated Criteria

Acceptance criteria in writing, because research tier is a tier, not an excuse

Ready To Start? Scope Your Non-GLP Bioanalysis.

Tailored non-GLP quote in 2 days.

Research Prices Should Still Buy Data You Can Use Again

Non-GLP fails when it quietly becomes sloppy. Ours runs on the same instruments and SOP discipline, minus only the compliance overhead you did not order.

Talk Science First? Ask Our Non-GLP Experts.

Discuss species, sample count and turnaround.

Non-GLP work here runs signature to results in two to four weeks, priced per assay and per sample, batches taken as they exist, so a three-compound pilot costs what a pilot should.
The fleet is the regulated fleet: twelve LC-MS systems, MSD, Luminex, ELISA, flow and PCR, so the numbers a discovery team banks do not dissolve when development reruns them under GLP.
Every method is documented as if validation is coming, because for the programs that survive, it is: the upgrade is a planned tightening with the record intact, never a second-lab restart.

2-4Weeks From Signature To Results On Research Projects

12LC-MS Systems Shared With The GLP Studies Next Door

What Does Non-GLP Work Cost?

Meaningfully less than GLP, because the study director formality, QAU study audit and ISR are real costs you are not buying. Pricing runs per assay and per sample with no minimum batch size, the quote names the tier and what it includes, and a senior scientist replies within two business days.

No Project Is Too Small To Start

Pilot studies and proof-of-concept questions are welcome, and they are how long sponsor relationships start. The regulated pages carry the mid-study cost lock; this one carries the research promise instead: start small, scale when the science works.

What Sponsors Say About Research Work That Held Up Later

Two thirds of the 100+ sponsors we work with each year return, and many of our longest relationships began with a pilot at this tier.

Director, PK

We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.
VP, Clinical Stage Biotech

The services are customized to our specific needs as opposed to standard packages.
Scientist, Clinical Stage Biotech

I appreciate your team’s willingness to answer questions and provide guidance.
VP, Development Operations

NorthEast BioLab’s scientists deliver high-quality data on time and within budget
Executive, Clinical Stage Biotech

There was an issue with half-life extrapolation, and NorthEast BioLab brought in the right experts to find the solution.
VP, Clinical Stage Biotech

There is also a willingness to develop new services to meet our needs even if not currently offered.

Non-GLP Now, GLP Later? Tell Us Your IND Date.

Share the molecule and species. We'll phase it.

Why Discovery Teams Run Their Research Tier Where The GLP Fleet Lives

No study or pilot is too small, and your samples run on our regulated instruments.

What You Receive

Ranked, reproducible numbers with stated acceptance criteria, never a mystery readout
A documented method file that upgrades to GLP validation without losing its history
Batch by batch scheduling with no minimum, priced per sample on an itemized quote
The straight tier call in writing, including when you should be paying for GLP instead

What We Need From You

The molecule and matrix with whatever is known, purity and vehicle constraints included
The decision the number feeds, because that is what sets both the tier and the price
Any prior data worth bridging to, so new plates line up with your existing history
Your decision date, since two to four weeks only helps if it lands before the meeting

Basics Of Bioanalysis | NorthEast BioLab

The Basics of Bioanalysis: How Do We Develop and Validate Your Bioanalytical Method?

Bioanalysis is an essential tool in drug discovery and development for determining the concentration of drugs and their metabolites in biological matrices….

Bioanalytical CRO Video Read More

One Dose Range Finding Week: A Representative Sprint, Step By Step

Plasma lands midweek and exposures are back before the next escalation, measured on our regulated fleet.

1. Three Dose Groups Land

DRF plasma arrives midweek; the study director needs exposures before the next escalation
2. Lean Method From The Library

A fit-for-purpose LC-MS/MS method adapted from the validated library, scoped in writing
3. Batches Run As They Are

Samples run batch by batch at research-tier pricing, no GLP overhead the data does not need
4. Exposures By Friday

Dose-exposure readout to the study director inside the week the decision actually has
5. The Winner Emerges

The tolerated, exposed dose group defines the next study and files into the DRF report
6. Graduation Held Ready

When the program earns an IND, the same method tightens to GLP with its history intact

Why Do Researchers Choose Our Lab For Non-GLP Work?

Because discovery speed in our lab does not mean discovery-grade science, and the method moves to GLP later without starting over.

Get Your Non-GLP Plan Reviewed By PhD Scientists.

Send your plan. We'll flag pitfalls before they cost you.

The regulated fleet at research pricing, with the same scientists on both tiers of work
Two to four weeks signature to results, per sample pricing and itemized, scoped quotes
Methods documented for the GLP upgrade, so early data keeps its value as programs grow
About 70% of our work is emerging biotech, and pilots here are how much of it started

Regulated And Inspected By: