Develop with confidence. Validate with precision. Deliver with regulatory readiness.
Alturas Analytics offers GLP-compliant bioanalytical method development and validation services for small molecules, proteins, peptides, and other complex modalities. Our team of scientists uses their extensive expertise to create methods that address unique problems associated with your analytical compound and biological matrix, while maintaining regulatory standards, expectations, and needs.
Our development of accurate, precise, and reproducible assays for global regulatory compliance is standard regardless of whether it supports a preclinical IND-enabling study or later-stage clinical programs. Our method development and validation process generates assays that meet global regulatory expectations through precise and reproducible testing. The development of each method includes thorough documentation and data integrity to achieve audit readiness.
Method development establishes assays optimized for sensitivity, specificity, and reproducibility, while method validation confirms that assays perform reliably according to U.S. FDA, EMA, and ICH bioanalytical validation expectations.
The team at Alturas Analytics delivers method development alongside method validation services, all under one roof. We direct every phase of the process from initial feasibility testing through final regulatory documentation with consistent procedures, transparent operations, and swift execution. The scientific teams at Alturas work together with our sponsors to develop methods which address drug development and research goals.
Our services include:
Your development goals depend heavily on both timeline adherence and data quality standards. Our team delivers reliable results by combining proactive communication with detailed planning and responsive execution to meet regulatory standards.
Explore more: Bioanalytical Services »
Initial feasibility studies evaluate extraction efficiency, assay sensitivity, calibration curve performance, and matrix interference to establish appropriate development parameters.
Our scientists optimize assay conditions to improve selectivity, sensitivity, reproducibility, and overall analytical performance in each relevant matrix. We carefully consider all sampling conditions from interference to aliquot size.
Validation studies assess accuracy, precision, selectivity, sensitivity, stability, recovery, and reproducibility in accordance with FDA, EMA, and ICH M10 guidance.
Alturas Analytics supports audit-ready reporting, bridging studies, cross-validation, and method transfer activities for global regulatory submissions.
Alturas Analytics supports a broad range of bioanalytical assay formats and analytical platforms designed to support preclinical and clinical drug development programs.
Our scientists develop and validate assays for:
Analytical platforms and technologies may include:
The bioanalytical scientists at our organization have developed and validated hundreds of assays for different drug modalities and matrices.
We support bioanalysis across a wide range of relevant matrices, including:
We start each project by performing a thorough analysis of your compound’s requirements and study specifications. Our team establishes a method that delivers specific results with high sensitivity and reproducibility, while adhering to all regulatory standards.
Related services: PK/TK Services » | LC-MS/MS Services »
Alturas Analytics employs state-of-the-art LC-MS/MS, LC-HRMS/MS, and GC-MS/MS equipment alongside validated software programs and established workflows to provide high-quality, regulatory-compliant results during every stage of development.
| Capability | Description |
| Assay Development & Optimization | Tailored methods for small molecules and biologics |
| Matrix Selection & Characterization | Evaluation and handling of plasma, serum, tissue homogenates, and other matrices |
| Method Validation (ICH M10 Guidelines) | Full GLP-compliant protocols for global submissions |
| Accuracy and Precision Studies | Inter- and intra-assay reproducibility assessments |
| Selectivity and Sensitivity Testing | Measurement of potential interference and matrix effects |
| Stability Assessments | Bench-top, freeze/thaw, and long-term sample stability testing |
| Partial Validations & Bridging Studies | Assay updates or alternative matrix validations |
| Platform Transfers & Cross-Validation | Full support for method transfers and equivalency studies |
| Regulatory Documentation & Audit Readiness | Comprehensive reports aligned with agency expectations |
The validation protocols at Alturas Analytics exist to fulfill all requirements set by the global regulatory authorities. Our Quality Assurance team maintains close contact with scientific staff to ensure that methods remain defensible and have complete traceable documentation.
Your final package includes:
We don’t just prepare for audit we help you feel ready to stand behind your data when it counts most. Quality Assurance »
Alturas Analytics stands out as the preferred choice of sponsors because we deliver data and confidence throughout all stages of development with a collaborative spirit. Alturas is not just a service provider; our goal is to act as an extension of your team to help move your programs forward efficiently.
Meet the team behind the science: Our Leadership »
The time to complete the method development and validation process is based on the complexity of the work. Each project begins with a detailed project schedule and set of milestones.
Yes. We support method transfer and cross-validation projects, which include both bridging studies and regulatory comparison procedures.
Absolutely. Our laboratory specializes in working with various biological samples, which includes processing limited quantities of cerebrospinal fluid (CSF), synovial fluid, and tissue homogenates.
Yes. Method development and validation services are conducted under good laboratory practice (GLP) conditions with complete quality assurance (QA) documentation and oversight.
Method development establishes assay conditions optimized for analytical performance, while method validation confirms that the method consistently produces reliable and reproducible results according to regulatory expectations.
Validation studies commonly evaluate assay accuracy, precision, selectivity, sensitivity, recovery, reproducibility, analyte stability, and limit of quantitation (LOQ) across relevant biological matrices.
Method validation ensures that the developed method is both fit-for-purpose and adheres to regulatory requirements including accuracy, precision, selectivity, reproducibility, stability, and limits of quantitation. Validation is a key step for the analysis of any regulated samples, allowing agencies like the FDA and EMA to reliably interpret preclinical and clinical results.
Does your organization need a method development or validation service to pass regulatory reviews while supporting preclinical and clinical operations?
Our team is ready to collaborate! Let’s discuss your compound, matrix, and submission goals to create a plan that helps you achieve your objectives.
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Related Services:
Bioanalytical Services
LC-MS/MS Services
PK/TK Services
Quality Assurance
Leadership Team
Dr. Jennifer Zimmer is the Chief Operating Officer at Alturas Analytics, Inc. and has worked in the field of bioanalysis for over 20 years. Dr. Zimmer is responsible for the overall operation of the Alturas Analytics laboratory, ensuring client deliverables are met while working laterally with Alturas QAU to maintain laboratory compliance with all procedures and regulations.
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