Regulatory-Ready Bioanalysis for Drug Development Programs
Emery Pharma provides quantitative bioanalytical services for pharmaceutical and biotechnology programs across discovery, preclinical, and clinical development. These services support the accurate quantification of drugs, metabolites, and biomarkers in complex biological matrices such as plasma, serum, urine, and tissues, generating the data needed to evaluate exposure, safety, efficacy, and translational performance throughout development.
Our capabilities include bioanalytical method development and validation, method transfer between laboratories, and targeted metabolomics analysis for biomarker and metabolite quantification. Using advanced mass spectrometry and ligand binding assay platforms, Emery Pharma delivers robust, regulatory-aligned datasets to support IND-enabling studies, clinical trials, and regulatory submissions.
Service Areas Supporting Exposure, Safety, and Regulatory Evaluation
Our quantitative bioanalytical services support the measurement of drugs, metabolites, and biomarkers across regulated and translational studies. Together, these capabilities help sponsors generate reliable data for method qualification, biological sample analysis, metabolite profiling, and regulatory decision-making.
Targeted Metabolomics Analysis
Description
Emery Pharma provides targeted metabolomics testing for the quantitative or qualitative detection of specific metabolites in complex biological matrices. These studies reveal metabolic pathways, verify biomarkers, and support translational research and disease-model investigations.
Methodology
Targeted metabolite profiling is performed using LC-MS/MS and high-resolution mass spectrometry (HRMS) platforms capable of detecting trace-level compounds with high sensitivity. Analytical workflows follow ICH M10 bioanalytical standards for quantitative assays and reporting practices recommended by the Metabolomics Standards Initiative (MSI), ensuring consistent data quality and interpretation across studies.
Deliverables
- Quantitative metabolite detection datasets
- Targeted metabolite profiling reports
- Biomarker validation data for translational studies
- Analytical interpretation supporting mechanistic research
- Regulatory-ready analytical documentation
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Our Scientists
Stephanie Tan, Ph.D. is an analytical biochemist with extensive expertise in analytical and bioanalytical method development supporting pharmaceutical research and drug development. At Emery Pharma, she serves as a Senior Scientist in the Chemistry Department, applying advanced chromatographic and mass spectrometry techniques to support quantitative analysis of drugs, metabolites, and biomarkers in complex biological matrices. She is proficient in HPLC/UPLC, LC-MS/MS, GC-MS/MS, and HRMS instrumentation for both qualitative and quantitative applications under R&D and GxP regulations. Stephanie’s background in method validation and analytical workflow optimization makes her well aligned to support quantitative bioanalysis programs requiring precise, regulatory-ready data generation.
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average lead time for study initiation
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Applicable Standards
USP 〈1224〉 Transfer of Analytical Procedures, ICH M10 Bioanalytical Method Validation, FDA/EMA Bioanalytical Guidances
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Target Product / Molecule Type
Small Molecules, Biologics, Peptides, Metabolites, Biomarkers, Oligonucleotides
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Instrumentation & Analytical Platforms
LC-MS/MS, HRMS, GC-MS, Plate reader/MSD, NMR
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Sample Requirements
Variable, depending on assay.
Why Choose Emery Pharma for Quantitative Bioanalytical Services
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GLP/GMP Compliance
Emery Pharma operates under strict GLP and cGMP standards, ensuring all bioanalytical methods and data are generated in compliance with regulatory frameworks such as ICH M10 and FDA guidelines, providing clients with confidence in data integrity for submissions. -
Regulatory Expertise
Our team designs assays and validation protocols aligned with global standards including ICH M10 bioanalytical method validation and USP 〈1224〉 method transfer. This regulatory alignment minimizes development risk and ensures analytical data withstands agency scrutiny.
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Breadth of Instrumentation and Methodologies
Emery Pharma leverages advanced HRMS, LC-MS/MS, and MSD platforms that enable sensitive and precise quantitation across diverse molecule types, from small molecules to biologics and peptides. This ensures versatile and reliable bioanalytical solutions. -
Rapid Turnaround Times
Integrated analytical workflows and experienced mass spectrometry specialists allow Emery Pharma to rapidly design assays, validate methods, and analyze biological samples, helping sponsors maintain momentum across preclinical and clinical programs. -
Cross-Industry Experience
Emery Pharma supports pharmaceutical and biotechnology organizations across discovery, preclinical research, and clinical development, applying bioanalytical expertise to diverse therapeutic modalities including small molecules, peptides, and biologics.
State-of-the-art instruments used in quantitative bioanalysis. Top left: HR LC-MS, top right: MSD instrument, Bottom: LC-MS
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Quantitative Bioanalytical Services FAQ
What is the difference between method development and validation?
Method development is the creative process of optimizing extraction and chromatography for a specific analyte. Validation is the formal "stress test" that proves the method meets regulatory standards (FDA/EMA) for accuracy, precision, and stability.