VP, Bioanalytical Development
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Advanced Analytical Testing Laboratory Services For Small Molecules, Cell/Gene Therapies, Biologics, Etc.
- Ultra-Sensitive Analytical Testing Using HPLC UV/DAD/Fluro, Mass Spec, qPCR/ddPCR, Meso Scale Discovery, ELISA, Etc.
- Reliable Method Development, GLP Method Validation, And Dose Formulation Analysis For Drug, Prodrug, And Metabolites
- Accurate Formulation Stability Assessment Under Diverse Storage, Stress, And Lab Conditions
- Characterization And Quality Control Of Drug Substance And Drug Product Assays Using Residual Impurity Testing
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Click below for answers to your Analytical Testing questions -
Ask Us About Your Study
Analytical testing services pertain to a wide range of chemical and microbiological assays. Analytical lab testing services include method development and validation, sample analysis for concentration confirmation, purity, homogeneity, and stability assays on preliminary formulations and finalized drug products for IND, NDA, and ANDA submissions. NorthEast BioLab offers sophisticated Analytical lab testing services to help detect, measure, and analyze the performance of your drug or personal care product.
What is Analytical Testing?
Analytical Testing: Method Development to Sample Analysis
Analytical testing services allow assessment of chemical compounds or biopharmaceutical materials in a specific and sensitive manner. Demand for a variety of analytical testing services is increasingly growing across a broad array of industry verticals ranging from biotech, pharmaceutical, environment, and food to personal care companies.
Drug research and development personnel utilize analytical services laboratory to determine the chemical and biological properties of chemical compounds for further development and enhancement. These testing services provide information on both, the safety profile of a drug candidate as well as its therapeutic or health impact.
Sponsors Love Our Bioanalytical Laboratory Services For Top Quality And Industry Leading Turnaround
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NorthEast BioLab is a responsive, collaborative, and reliable partner
We trust NorthEast BioLab to design and execute streamlined, impactful bioanalytical projects
We found their integrity as refreshing as readiness to provide creative scientific input and high-quality data
We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.
NorthEast BioLab tremendously supported us in reproducing our critical lab discoveries for drug metabolism
NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.
“NorthEast BioLab goes the extra mile. We look forward to more meaningful collaborations.”
NorthEast BioLab offers a science-based, hands-on approach to the latest bioanalytical platforms
We are thrilled to complete our bioanalytical studies with their top quality and incredibly responsive team.
We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.
Our projects with NorthEast BioLab include successful method development, validation, stability studies during Clinical Phase I – IV studies.
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.
Our latest successful study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis.
This study, same as all other bioanalytical studies, was completed with top quality and reporting standard with incredible responsiveness.
NorthEast BioLab’s scientists deliver high-quality data on time and within budget
Tackle Your Analytical Testing With Our Veteran Team Now!
Which Analytical Testing services do we offer?
Analytical Testing services by NorthEast BioLab
NorthEast BioLab offers comprehensive analytical testing services for chemical entity evaluation as well as drug discovery and development. These drug testing and analysis services are provided using various analytical techniques include LC-MS/MS, LC/UV, LU/Fluorescence, ELISA Assay, Luminex, and Western Blot among other techniques.
Our scientists utilize effective method development, transfer, set-up, and validation techniques to identify, separate, and quantitate drug and metabolites in biological fluids. We provide the following analytical testing laboratory services:
Bioanalysis or Bioanalytical Testing
NorthEast BioLab offers the following bioanalysis services:
- Analysis of chemicals, drug, and metabolites
- Preclinical non-GLP and GLP analysis in
- Rodents – Rat, Mice
- Non-Rodents – Rabbit, Dog, Pig, Goat, Sheep, Non-human primate (NHP)
- Clinical studies ranging from Phase I -IV
- Bioavailability and bioequivalence studies
- Assessment of drug-drug interactions
- Chiral or enantiomeric separations
- Stabilization methods for analytes
Biomarker Testing
NorthEast BioLab performs biomarker tests to assess the exposure, susceptibility, or impact of a drug compound on an illness or disease. Specifically, our team offers biomarker analytical testing services below to ensure safe drug product for clinical trials:
- Fluid and tissue-based biomarkers
- Method development and qualification of novel biomarkers
- Rapid GLP validation of established qualified assays
- GCP measurement of biomarkers in biological samples from Clinical trials
Registered And Inspected By Various Regulatory Agencies
Don’t Wait, Start Your Analytical Testing Service Company Today!
Why choose us for your Analytical Laboratory Services?
Proficient Analytical Laboratory Services tailored to R&D needs of Biotech and Cosmetic Companies
NorthEast BioLab has in-depth expertise in analytical lab services to perform in-vitro and in-vivo testing of chemicals and assessing their efficacy for intended therapeutic value. We deliver superbly on characterization, purity, safety, and efficacy analysis of your various chemical formulations by our in-house chemistry and biology experts. Our veteran team has steadily developed outstanding processes and standard operating procedures (SOPs) for streamlining your drug testing and analysis given our 20+ years of experience as an analytical lab. We are committed to developing and validating robust bioanalytical methods per FDA guidance, given your primary objective of expedited FDA drug approval.
The Basics of Bioanalysis
Bioanalysis is an essential tool in drug discovery and development for determining the concentration of drugs and their metabolites as well as various pharmacodynamics biomarkers in biological fluids. In these analyses, scientists use developed an….
