Bioanalytical CRO for Biotech: 750+ Studies, 500+ Methods

Q: Who owns NorthEast BioLab?

NorthEast BioLab is part of Normec Group, an Amsterdam-headquartered European testing, inspection, certification and compliance group with 160+ locations. What that changes for a sponsor: staying power and resources. What it does not change: the founders’ operating model, the leadership on your study, or the building your samples live in.

Q: Where do you stand on the BIOSECURE Act?

Clear of it, and documented: no adversary ownership anywhere in the chain, parent included, US data hosting, and no reliance on 1260H-listed entities. A signed statement of compliance is available on request, and the Quality & Compliance page carries the full position.

Q: How big are you, honestly?

Thirty-plus people, inside a group of 6,500. Big enough that 100+ sponsors run work here every year; small enough that the scientist who validated your method answers your email. That size is a choice, and this page explains why.

Q: Do you subcontract any of the work?

The bioanalysis, never: we never subcontract bioanalysis, so you never need a cross-vendor bridging study. Where a program needs work we deliberately do not do in-house, we say so plainly and route it, with the split documented, never blurred.

Q: Where does the work physically happen?

At 35 Worth Avenue, Hamden, Connecticut, one facility, and your samples never leave the country at any point. Chain of custody runs in Watson LIMS from accession through storage, and sponsors are welcome to come see the benches their study runs on.

Q: How long have your scientists actually been there?

The founder has been at the bench since 2003, the scientific leads have run their platforms here for five-plus years, and the wider PhD bench averages three-plus years here, with senior scientists at 18+ years in industry. The scientist who develops your method runs your samples.

Q: What happens to our program if you are acquired, or we are?

It keeps running, and that is by design rather than assurance. Methods are documented to survive transfer, custody lives in Watson LIMS, 85+ SOPs govern the work, and the group behind us underwrites continuity. The method history and the people stay in one place.

Make Our Bioanalytical Lab Your Unfair Advantage.

Many of your competitors already do; 100+ sponsors run studies here every year.

Boutique Alternative In A Consolidating Industry, Sized For Direct Scientist Access
Leadership That Still Reads The Raw Data Before It Leaves The Building
One In Three Sponsors Has Worked With Us For More Than Three Years
700+ Sponsor Studies, With Our Data Inside Sponsor IND, NDA, ANDA, BLA Filings

“We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.”

Sr. Associate Dir., Clinical Trials

Regulated And Inspected By:

Our Bioanalytical Lab's Story, Counted Four Ways

2003 Founded, Hamden CT

20+ Years In Bioanalysis

100+ Sponsors Every Year

70% Sponsors, Emerging Biotech

Twenty Years, One Bioanalytical Capability At A Time

Where we started is not where we stopped; the lab keeps rebuilding itself around what biotech needs next. Newest first, back to 2003.

A boutique with a group behind it
Part of Normec Group: a European network and the infrastructure of a 6,500-person organization behind the same Hamden building, with the founders still involved. In 2026, Stephen Rundlett, PhD, joined as Head of Bioanalytical Operations after 30+ years at SGS, Precision for Medicine and Intertek.
Partners
The compliance stack deepens
CLIA certification and ISO 9001 joined GLP and GCLP compliance, with CAP accreditation following.
Quality & Compliance
The systems mindset
An electronic QMS came online beside Watson LIMS running chain of custody. The bet behind the spend: quality should live in systems, not in any one person’s memory. Flow cytometry came in-house the same year.
Flow Cytometry
The building we designed
Moved in December into the current facility at 35 Worth Avenue, Hamden: 19,000 square feet, four stories, custom-designed around bioanalytical workflow, more than double the footprint it replaced. ddPCR and qPCR joined the molecular floor the same year.
ddPCR & qPCR Facility & Equipment
The lab chose its identity
Scaled PhD hiring through a pandemic the lab worked straight through, and made the deliberate turn from cookie-cutter assays to custom problem solving.
Our Team
Large molecule, deliberately
Large molecule work became a stated priority, and the ELISA, MSD and cell-based benches began growing toward today’s near-even split with LC-MS.
Immunoassay MSD Assay
The business side gets built
After fifteen years of scientists selling to scientists, the company built business development, marketing and strategic investment into a discipline of its own.
Why Us
The record starts compounding
The sponsor roster compounds, and the audit record with it. Five FDA inspections sit in the record, and sponsor quality teams audit the lab far more often than agencies do.
A lab of our own
Moved into the company’s own laboratory, roughly 8,000 square feet, and built an early clinical LC-MS practice, primarily small molecule PK.
LC-MS/MS
Where it started
Ex-Bayer scientists, backed by healthcare investors, founded the company in March, with the first benches standing inside a Bayer facility, on a working belief the lab still runs on: deep-rooted partnerships over transactions.

Ready To Start? Scope Your Bioanalytical Study.

Itemized bioanalysis quote in 2 days.

The Bioanalytical CRO That Builds What Biotech Needs Next

Founded in 2003, run on four unedited values, and engineered so your program keeps its lab whoever owns it.

Big Or Seed-Stage Biotech? High-Standard Bioanalysis.

Share the study. Senior scientists either way.

The Founding

Vipin Agarwal and fellow ex-Bayer scientists founded the lab in March 2003, and stayed.
The bet was that treating life-threatening disease takes deep-rooted partnerships.
The north star never changed, help biotech accelerate, and take the work others turn away.

The Lab Today

Twelve LC-MS/MS beside a full immunoassay, PCR, flow and cell-based fleet.
Nearly half of a typical year is large molecule, and seven in ten studies are clinical.
40+ clinical and 15+ IND-enabling studies active; 30%+ of clinical work for NDA/BLA.

Four Core Values Since 2003

Swiftness of small business: nimble beats big when your timeline is real.
An unending quest for knowledge: experimentation fuels the inner scientist daily.
A positive and lasting impact: we help find the right treatment, for our families and everyone else’s.
Synergistic partnership: say what we mean, and mean what we say; no study or pilot too small.

The Lab Tomorrow

A 6,500-person group behind the lab, with management depth to tap when a program needs it.
The founders remain involved, and the leadership on your study is unchanged.
Methods documented for transfer, Watson LIMS custody, 85+ SOPs under an eQMS. Your program keeps its lab.

What A Decade Of Sponsors Sounds Like

Quoted with permission, names withheld. Yours would be too.

Worried About Being a Small Bioanalysis Account?

Senior bioanalytical scientists on every study.

Sr. Associate Dir., Clinical Trials
★★★★★
We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.
President & CSO, Biotech
★★★★★
We found their integrity as refreshing as readiness to provide creative scientific input and high-quality data.
VP, Biomarker Development
★★★★★
NorthEast BioLab is a responsive, collaborative, and reliable partner.
Executive Director, Pharmacokinetics
★★★★★
We trust NorthEast BioLab to design and execute streamlined, impactful bioanalytical projects.
Head, Bioanalytical Development
★★★★★
NorthEast BioLab goes the extra mile. We look forward to more meaningful collaborations.
VP, Development Operations
★★★★★
NorthEast BioLab’s scientists deliver high-quality data on time and within budget.