Alturas Analytics provides LC-MS/MS services that help sponsors make confident decisions during all stages of drug development. Our LC-MS/MS platforms generate precise and reliable submission-ready data for both small-molecule and complex therapeutic programs throughout development, from early-stage assays through to clinical sample analyses that inform regulatory filings.
Our quantitative expertise prepares your data for regulatory review when you are developing new pharmacological entities.
Our scientists assist your project throughout feasibility evaluation, formal method validation, and clinical execution. The LC-MS/MS services at Alturas include:
Learn More: Development and Validation of LC-MS/MS Methods
LC-MS/MS is widely used throughout drug development because of its sensitivity, specificity, and ability to quantify compounds and their metabolites in complex biological matrices.
Alturas supports LC-MS/MS applications including:
Our workflows are designed to generate reproducible data that supports decision-making from early discovery through regulatory approval.
The laboratory at Alturas Analytics provides analytical support for various biological samples and chemical compounds. We provide:
Our team demonstrates exceptional ability to handle extraction variations and method transfers between development and regulated environments.
Alturas Analytics supports quantitative LC-MS/MS and GC-MS/MS analysis across a wide range of biological matrices commonly used throughout drug development programs.
Our scientists routinely develop and validate methods for:
Our team evaluates matrix effects, recovery, stability, and extraction performance during method development to ensure reliable quantitation throughout sample analysis and regulatory submission activities.
Related Project: GC-MS/MS Tuberculosis Urine Biomarker Case Study
Our lab uses industry-standard instrumentation optimized for accuracy, precision, and throughput.
Explore Our Tech Focus: Alturas Analytics Instrumentation
Alturas Analytics operates under GLP compliance and follows ICH M10 guidances for method validation and data reporting procedures. We offer:
Explore More: Alturas Analytics Quality
Alturas Analytics has supported bioanalytical studies across numerous therapeutic areas throughout discovery, preclinical, and clinical development.
Our program experience includes:
Whether supporting animal models, first-in-human studies, or late-phase clinical programs, our scientists develop analytical approaches tailored to the unique requirements of each therapeutic area and molecule type.
Our high resolution mass spectrometry capabilities, typically as LC-HRMS/MS, support both qualitative and quantitative workflows. These methods are ideal for protein quantitation, metabolite identification, biomarker discovery, and nontargeted screening. When used to its full potential, HRMS can deliver precise mass accuracy and robust sensitivity to provide deeper insight across discovery and regulated studies.
Scientists at Alturas Analytics employ GC-MS/MS techniques when LC-MS/MS methods are inappropriate to achieve complete detection of some substances encountered in therapeutic programs. Expert optimization of GC-MS/MS offers sensitive and selective detection methods for volatile and semi-volatile compounds.
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We stringently adhere to the ICH M10 bioanalytical method validation guidance in performing constant checks for accuracy and precision, as well as selectivity, sensitivity, and reproducibility.
Yes. Bioanalytical data generated at Alturas is GLP-compliant and ready for submission to the FDA, EMA, and other regulatory bodies.
LC-MS/MS is commonly used for small molecules, metabolites, peptides, biomarkers, and select biologic compounds. Method development strategies are tailored to the chemical and biological properties of each analyte and the particular matrix.
GC-MS/MS is often preferred for volatile or semi-volatile compounds that are not well suited for liquid chromatography workflows. Alturas scientists can recommend the most appropriate analytical platform based on your compounds’ characteristics and study objectives.
Yes. Alturas operates under GLP-compliant processes and follows current regulatory guidance, including ICH M10 recommendations for bioanalytical method validation and sample analysis.
Need defensible, fast-turnaround LC-MS/MS or GC-MS/MS support for your drug development program?
The first step to start a data-driven partnership with one of our Alturas Analytics scientists begins with requesting a consultation. Ask us anything – especially questions that you wish other providers had asked!
Method Development and Validation
Chad has over 24 years of related experience as an analytical scientist with over 20 years focused on bioanalysis at Alturas Analytics. Chad is responsible for supervision of the analytical method development team in supporting method validations and sample analysis and Study Director/Principal Investigator on GLP and clinical studies, providing technical oversight to clients across all therapeutic areas.
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