GLP Method Validation To FDA BMV And ICH M10
- Accuracy, precision, stability and selectivity documented on LC-MS/MS or ligand binding
- Incurred sample reanalysis written into the validation plan, not bolted on after a finding
Services
Platforms
Solutions
About Us
Resources
De-Risk Your GLP Study, SOPs to Audit-Ready Data.
Brief PhDs on your study type, species and timeline.- GLP Method Validation And Sample Analysis For TK, PK And BA/BE On Every Platform
- Named Study Directors, An Independent QAU And 85+ SOPs On A Dot-Compliance eQMS
- DEA And Connecticut Schedule I Through IV For Controlled Substance Bioanalysis
- Honest Tier Advice, So You Never Pay GLP Rates For Work That Does Not Need Them
Regulated And Inspected By:
What A GLP Study At Our Lab Actually Includes
GLP is a set of obligations somebody must carry: a study director accountable for every phase, a QAU auditing against 85+ SOPs, ISR on real samples. The records archive under 21 CFR Part 58.
GLP Sample Analysis Behind TK, PK And BA/BE
- Toxicokinetics behind your IND, PK and bioequivalence behind your NDA, on twelve LC-MS
- Batches scheduled to your in-life or clinical calendar, with exposures cohort by cohort
A Named Study Director On Every GLP Study
- One accountable scientist end to end, the Part 58 role FDA inspectors interview first
- Protocol, deviations and report all carry that signature, so ownership is never diffuse
An Independent QAU Auditing Every GLP Study
- Protocol review, in-process inspections and report audit by a unit outside operations
- Your own QA team welcome any time, with SOPs, study files and LIMS trails inspectable
Controlled Substances, Schedule I Through IV
- DEA and Connecticut licenses held on site, so scheduled compounds run without a hand-off
- Vault storage, dispensing logs and reconciliation handled inside the same quality system
Fit-For-Purpose Tiers When GLP Is Not Needed
- Discovery PK, DRF and screening tiers on the same instruments with lighter documentation
- We say which tier your study needs in the quote, and upgrading later is a planned step
What An FDA Inspector Reads First
Protocol, validation report, custody trail, raw data, QAU statement, archive. Chromatograms and audit trails reconcile to every reported number.
-
The Protocol And The Study Director
A QAU-reviewed protocol and a named accountable scientist, before any sample thaws
-
The Validation Report
Method proven to FDA guidance and ICH M10, with ISR designed in, not improvised
Method Validation -
The Custody Trail
Watson LIMS from receipt through storage, monitored around the clock
Central Lab Services -
The Raw Data Itself
Chromatograms and audit trails that reconcile to every reported number
-
The QAU Statement
Independent audit before the study director signs, five FDA inspections deep
-
The Archive
21 CFR Part 58 records that resurface intact years later, on request
Ready To Start? Scope Your GLP Study.
Tailored GLP quote in 2 days.
GLP Built For Inspection, With No Queue Between You And The Study Director
GLP fails on training records, deviations handled quietly and data trails that stop. Our QAU audits for each of those.
Talk Science First? Book a Call With Our GLP Experts.
Discuss study type, SOPs and audit scope.- Validation runs two to three weeks on LC-MS/MS and four to six on ligand binding even under GLP, because the quality tier changes the documentation, not the pace your program moves at.
- Twelve LC-MS systems, duplicated ligand binding and PCR platforms and a 30+ scientist team mean a pivotal tox study and a BE study can run side by side without queueing against you.
- Five FDA inspections and regular sponsor audits keep the system proven: send your QA team with a checklist and the QAU hosts them through SOPs, study files and Watson LIMS audit trails.
5FDA Inspections Of This Laboratory Across 20+ Years
85+Controlled SOPs Enforced Under The Dot-Compliance eQMS
What Does GLP Bioanalysis Cost?
GLP costs more than fit-for-purpose because the study director, QAU audit and ISR are real work, and the quote shows those lines rather than burying them. Validation runs two to three weeks on LC-MS/MS and four to six on ligand binding, and if your study does not need GLP, the quote says so and prices the lighter tier instead.
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 on regulated studies that outlive the quarter they were quoted in.
Sponsors On Placing Regulated Work With Us, Verbatim
Auditors judge our records; sponsors judge the years. Two thirds of each year's 100+ sponsors return.
-
SVP Quality & Compliance, Biotech
We are thrilled to complete our bioanalytical studies with their top quality and incredibly responsive team.
-
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.
-
Sr. Associate Dir., Clinical Trials
We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.
-
Executive, Clinical Stage Biotech
There was an issue with half-life extrapolation, and NorthEast BioLab brought in the right experts to find the solution.
-
Head, PK
This study, same as all other bioanalytical studies, was completed with top quality and reporting standard with incredible responsiveness.
-
CRO Partner
Really appreciate the Co-Presidents’ hands-on approach.
GLP or Non-GLP? Tell Us Your Submission Target.
Share the study type. We'll tell you what is required.Why Do Sponsors Place The Studies FDA Reads Closely Under Our GLP?
Two decades of GLP bioequivalence and toxicokinetics, the studies where the data alone decides, built the system every study in our lab inherits.
What You Receive
- A validated method report your submission cites, with ISR results inside the package
- An audited bioanalytical report signed by a named study director, QAU review complete
- SEND or eCTD ready data tables from WinNonlin NCA, built for filing rather than rework
- Records archived under 21 CFR Part 58, retrievable whenever an agency asks a question
What We Need From You
- The study protocol or draft, so the bioanalytical plan and TK draws align before dosing
- Reference standard with certificates, sized to the compound supply you have on hand
- Your regulatory context: IND, NDA or ANDA, since it sets the validation scope quoted
- A QA contact if you want to audit first, and most sponsors placing GLP work here do
Good Laboratory Practices for Bioanalytical Laboratories
Conceptually understanding bioanalysis can be difficult, but good introductory resources enable a basic understanding. In simple words bioanalysis, is a testing tool used in drug discovery and development to determine the concentration of drugs and metabolites in….
One GLP Study Through The QAU Gates: A Representative Path, Step By Step
Protocol signed, samples logged, runs audited, report reconciled, records archived. Every checkpoint your auditor will ask about is in the walk-through.
-
1. Protocol Signed
QAU reviewed protocol, study director named, acceptance criteria fixed
-
2. Method Validated
FDA and ICH M10 parameters documented, ISR planned into the study
-
3. Samples Accessioned
Watson LIMS custody from receipt, storage monitored around the clock
-
4. Batches Analyzed
TK or PK batches to the study calendar, exposures cohort by cohort
-
5. ISR Passed
Incurred samples reanalyzed and reconciled, the check inspectors ask about
-
6. QAU Audit, Then Signature
Independent audit of data and report before the study director signs
-
7. Archived, Submitted
SEND or eCTD ready tables out, records archived under 21 CFR Part 58
Why Do QA Units Choose Our Lab For GLP Studies?
Because your QA team can audit before awarding a study, and five FDA inspections say what they will find.
Get Your GLP Study Design Reviewed By PhD Scientists.
Send your plan. We'll flag pitfalls before they cost you.- Five FDA inspections and 85+ SOPs under an independent QAU on a Dot-Compliance eQMS
- US based analysis and storage with DEA Schedule I-IV, samples never leave the country
- 700+ sponsor studies delivered, and the honest call on tier before you spend on GLP
- About 70% of our work is emerging biotech, so your study is run by senior scientists
Regulated And Inspected By:
Build The Submission In A Lab That Inspectors Have Already Met
Send the protocol and regulatory context. A senior scientist scopes validation, analysis and tier, on the platforms linked below.
Related FAQs
What QA units ask before qualifying a vendor, answered.
What makes a laboratory GLP?
Do we need GLP for our study?
What is ISR and why does it matter?
Can you handle scheduled compounds?
Can our QA team audit you before we place the study?
How long are study records kept?
Does GLP slow the study down?
Explore More Solutions
GLP is the frame. Every regulated assay we run sits inside it.
