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Will Your Bioanalytical Lab Hold Up In A Real Audit?
One to two sponsor audits run here every month, and your QA is welcome next.- An Independent Quality Assurance Unit With Sight Of Every Regulated Study
- 85+ SOPs, Watson LIMS Custody And An Electronic QMS Keep Quality In Systems, Not Memory
- CAP, CLIA, ISO 9001, DEA & CT Schedule I-IV, On Top Of GLP And GCLP
- Signed BIOSECURE Statement, No Adversary-Country Ownership, All Study Data Hosted In The US
“We are thrilled to complete our bioanalytical studies with their top quality and incredibly responsive team.”
Regulated And Inspected By:
Five Layers Between Your Samples And A Regulatory Finding
From the independent QAU to the certificate stack, each layer offers something your auditor can test rather than take on faith.
An independent QAU
The QAU, Puja Patel and Ishita Desai, reports to the Head of Bioanalytical Operations and stays independent of the scientists running studies, with sight of every regulated study: protocol review, in-process inspections, data audit and final report review. The person who approves your data does not answer to the person who produced it.
Systems, not memory
Watson LIMS carries chain of custody from accession through storage and disposal. An electronic QMS runs document control, training, deviations and CAPA across 85+ SOPs. Quality lives in systems, which is exactly what your auditors will test.
Method validation done whole
Full validation with stability against FDA and ICH M10 expectations, then regulated sample analysis with incurred sample reanalysis, documented so the submission reads as one record.
Inspected, and audited between inspections
The FDA has inspected this laboratory five times across its history, and sponsor quality teams audit us routinely in between. Your QA is welcome to do the same before a single sample ships, and we walk your quality team through every outcome under CDA, including any Form 483 observations and how each was closed.
The certificate stack
GLP and GCLP on the regulated tiers. CAP and CLIA on the clinical side. ISO 9001 on the management system. DEA and Connecticut Schedule I-IV registrations. Training across FDA, CDC, OSHA, EPA and HIPAA obligations.
What Your Diligence Team Can Request Today
The guidance we operate against, FDA Bioanalytical Method Validation aligned to ICH M10, 21 CFR Part 58, GCLP, CLIA, ISO 9001 and 21 CFR Part 11.
The Package, Item By Item
- The SOP index, and the SOPs your checklist calls for
- The QAU organization chart and reporting line
- Training matrices for the scientists on your study
- Equipment validation, calibration and maintenance records
- The insurance certificate set
- The signed BIOSECURE Act statement of compliance
- The business continuity and disaster recovery summary
- FDA inspection history and outcomes, walked through directly
- A template quality agreement, ready for redline
- A completed standard vendor questionnaire
- The instrument inventory, by model and count
- 21 CFR Part 11 and CSV status for Watson LIMS and the eQMS
- The data and sample retention policy
- CLIA and CAP numbers and the ISO certifying body
- UEI and CAGE codes for government bids
- Template method validation and sample analysis reports
The package ships against one CDA in two business days, because the documents exist before you ask.
Where This Lab Stands On The BIOSECURE Act
- No adversary ownership, parent included; no entity of China, Russia, Iran or North Korea holds any interest
- All client study data hosted and stored within the United States
- No regulated activity relies on any designated or Section 1260H-listed company
- A signed statement of compliance on request, refreshed when OMB publishes its list
Enacted December 2025 as Section 851 of the FY2026 NDAA.
Need Your QA to Sign Off on Our Bioanalytical Lab?
Our independent QAU answers their checklist.What Sponsors Say About The Quality, Verbatim
Quoted with permission, names withheld. Yours would be too.
Unsure Which Regulatory Tier Your Bioanalysis Needs?
Tell us the submission. We’ll set the tier.- Executive Director, Drug Research
★★★★★
NorthEast BioLab provides critical insight, and are compliant with regulatory standards and industry best practices.
- Sr. Dir., Bioanalytical Development & QC
★★★★★
NorthEast BioLab offers a science-based, hands-on approach to the latest bioanalytical platforms.
- VP, Bioanalytical Development
★★★★★
NorthEast BioLab is the most responsive and thorough bioanalysis lab services CRO.
- Head, PK
★★★★★
This study, same as all other bioanalytical studies, was completed with top quality and reporting standard with incredible responsiveness.
- Dir., Bioequivalence Testing
★★★★★
Our latest successful study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis.
- VP, Head of Clinical Operations
★★★★★
Our projects with NorthEast BioLab include successful method development, validation, stability studies during Clinical Phase I-IV studies.
Registered And Inspected By Various Regulatory Agencies
NorthEast BioLab Jobs: Learn And Grow With A Diligent Team Of Bioanalytical Experts!
Join NorthEast BioLab, a bioanalytical CRO lab based in Hamden, CT, with openings in analytical chemistry, biochemistry, quality assurance and project management.
Explore Our Services And Expertise
A distinct track record of advancing your research and GLP bioanalysis from discovery to development and beyond.
Learn More About Drug Development And Bioanalysis
The latest on the drug discovery and development process, for bringing your analytical research to success.
Related FAQs
Answers to the questions quality teams actually ask, popular among our potential sponsors.
