GLP Method Development, Validation And ISR
- Validated to FDA guidance and ICH M10 on LC-MS/MS or ligand binding, ISR built into the plan
- Fit-for-purpose tiers for discovery and DRF work, so you never pay GLP rates without need
Services
Platforms
Solutions
About Us
Resources
De-Risk Your Preclinical Bioanalysis, POC to IND.
Brief PhDs on your molecule, species and timeline.- GLP Toxicokinetics And PK Across Rodent, Dog, Minipig, NHP And Every Major Matrix
- Dose Formulation Verification, In Vitro ADME And Met ID Under The Same Study Roof
- Biodistribution, Shedding And VCN By Validated qPCR And ddPCR For Gene Therapies
- 150+ IND Enabling Studies Delivered, With Methods That Carry Into Your Clinical Trial
Regulated And Inspected By:
One Lab From Dose Formulation To The IND Package
About 28% of this year's work is preclinical, most of it bound for an IND.
Toxicokinetics Across Every Study Species
- Rat, mouse, rabbit, dog, minipig, goat, sheep and NHP in plasma, serum, urine and tissues
- Cohort by cohort exposures to your study director before the next dosing day, not after
Dose Formulation Analysis Before First Dose
- Concentration, homogeneity and stability of the dosing article, verified before animals dose
- HPLC and LC-MS methods for solutions, suspensions and diets, run to the in-life calendar
In Vitro ADME And Metabolite Identification
- Microsomal and hepatocyte stability, MDCK-MDR1 permeability, protein binding, CYP profiling
- Metabolite identification on the Q Exactive HF Orbitrap ahead of your first-in-human dose
Biodistribution, Shedding And VCN By ddPCR
- Validated ddPCR and qPCR for vector copy number, tissue biodistribution and shedding panels
- Tissue panels processed on KingFisher and TissueLyser workflows at full preclinical scale
The Bioanalytical Half Behind Your Tox CRO
- TK and dose formulation behind your vivarium or one of our partners, on the in-life dates
- No animal facility here, so your tox CRO gains a partner laboratory, never a competitor
What The IND Reviewer Asks, And Where It Comes From
Reviewers want proof the dose was real, the exposure measured and the drug's distribution known. From mouse to NHP, each answer starts with formulation checked before day one.
-
Was The Dose What You Claim
Dose formulation verified for concentration, homogeneity and stability before day one
Dose Formulation -
Was Exposure Really Measured
Validated TK methods, exposures cohort by cohort with ISR on regulated studies
Tox Study -
Was It GLP Throughout
Part 58 conduct: protocol, study director, and a QAU audit trail behind every number
GLP Laboratory -
Where Did The Drug Go
Tissue distribution and vector copy number by validated ddPCR where the modality demands it
ddPCR Service, qPCR -
Did The Animals React
Preclinical immunogenicity tiers run beside TK on the same accessions
Immunogenicity -
Can The Agency Read It
WinNonlin parameters in SEND-ready tables, the audited report your IND files
Ready To Start? Scope Your Preclinical Bioanalysis.
Tailored preclinical quote in 2 days.
Your In-Life Dates Are Fixed, So The Bioanalysis Cannot Be What Slips
IND-enabling work fails on documentation debt: decisions made informally that an inspector later asks about. Ours are written down as they happen.
Talk Science First? Ask Our Preclinical Experts.
Discuss species, timeline and IND scope.- TK exposures return cohort by cohort while the study is still dosing, so your study director sees parent and metabolite levels before the next escalation, not after the in-life phase ends.
- Twelve LC-MS systems with duplicated ligand binding and PCR platforms absorb tox study peaks, so a fifty-timepoint dosing day is a scheduling event here rather than anyone’s bottleneck.
- Quality is the floor, not the pitch: GLP under 21 CFR Part 58, an independent QAU, five FDA inspections and ISR built into validation plans, all inspectable on any audit you book.
150+Preclinical Studies Delivered, Most Inside IND Packages
15+Preclinical Studies Active In This Laboratory Right Now
What Does Preclinical Bioanalysis Cost?
Pricing is per assay and per sample, with no minimum batch size, so a DRF screen and a pivotal GLP tox study are quoted on what they need. Method validation runs two to three weeks on LC-MS/MS and four to six on ligand binding, small projects run signature to results in two to four weeks, 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 most when the tox program behind your IND spans seasons of in-life work.
Word For Word: Sponsors And Tox CRO Partners On The Preclinical Work
The method that carries your tox study usually stays on for the clinic. More than 90% of methods developed in our lab go on to run study samples with us.
-
CRO Partner
Really appreciate the Co-Presidents’ hands-on approach.
-
Co-Founder, Biotech & University PI
NorthEast BioLab tremendously supported us in reproducing our critical lab discoveries for drug metabolism
-
Executive Director, Pharmacokinetics
We trust NorthEast BioLab to design and execute streamlined, impactful bioanalytical projects
-
VP, Clinical Stage Biotech
The services are customized to our specific needs as opposed to standard packages.
-
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.
-
Director, PK
We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.
Not Sure What the IND Needs? Tell Us Your Target Date.
Share modality and species. We'll map the package.Why Do Biotechs And Tox CROs Bring Us The Bioanalysis Their IND Rests On?
IND-enabling bioanalysis has been our work for 20+ years, from rodent studies to NHP.
What You Receive
- A validated method package built around your compound supply, every parameter documented
- SEND ready toxicokinetic tables from WinNonlin NCA, timed to your submission calendar
- An audited GLP report with incurred sample reanalysis results your QA team can defend
- Raw data and records archived per 21 CFR Part 58, retrievable for the life of the program
What We Need From You
- The draft protocol and dosing schedule, in time to align TK draws with in-life dates
- Reference standard with certificates, sized to the milligrams you actually have to spare
- The dosing article and formulation details, before first dose so verification can run
- Your tox CRO contact, so draw schedules and shipments sync without you in the middle
Complete Guide on IND Enabling Toxicology Studies
In pharmaceutical discovery and development, many drug substances and their formulations are generated. However, the vast majority of these compounds will not be suitable as final products for commercialization….
One GLP Tox Study, Start To SEND: A Representative Program, Step By Step
We verify the dosing article before first dose, read exposures while dosing is under way and build the tables for submission. The steps follow the order a reviewer will reconstruct.
-
1. Dosing Article Verified
Concentration, homogeneity and stability confirmed before first dose
-
2. Day One TK Draws
Samples courier from your vivarium and accession into Watson LIMS same day
-
3. Exposures Between Dosing Days
Cohort by cohort TK to the study director before the next escalation
-
4. Terminal Tissues
Biodistribution and VCN by validated ddPCR, tissues via TissueLyser workflows
-
5. ADA At Termination
Preclinical immunogenicity tiers run beside TK on the same accession
-
6. NCA, SEND, Audited Report
WinNonlin parameters, SEND ready tables and the report your IND files
Why Do Sponsors Choose Our Lab For IND-Enabling Bioanalysis?
Because five FDA inspections have walked through our quality system, and the study file reads the same in year three as in week one.
Get Your IND Bioanalysis Plan Reviewed By PhDs.
Send your plan. We'll flag pitfalls before they cost you.- GLP under 21 CFR Part 58 with an independent QAU, five FDA inspections and 85+ SOPs
- US based analysis and storage, so your compound and samples never leave the country
- 150+ preclinical studies with 90%+ of methods carried forward into clinical programs
- About 70% of our work is emerging biotech, so your program gets senior scientists
Regulated And Inspected By:
Your IND Is Booked Long Before The Data Exists, So We Work To That Clock
Send the draft protocol and dosing schedule. A senior scientist scopes TK, ADME and formulation against your filing date, on the platforms linked below.
Related FAQs
What nonclinical leads ask before an IND-enabling study, answered.
Do we need GLP for this study, or is fit-for-purpose enough?
Can you work with our tox CRO?
We only have milligrams of compound. Is that enough?
Which species and matrices do you cover?
How fast can TK data reach our study director?
Can you run gene therapy biodistribution?
What lands in our IND from your work?
What happens to the method after the IND?
Explore More Solutions
IND-enabling bioanalysis sits beside dose formulation, TK and ADME, and those programs are ours as well.
