Develop with confidence. Validate with precision. Deliver with regulatory readiness.
Alturas Analytics offers GLP-compliant bioanalytical method development and validation services for small molecules, together with protein, peptide, 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.
The development of accurate, precise, and reproducible assays for global regulatory compliance is standard regardless of whether is supports a preclinical IND enabling study or later stage clinical programs. Our method development and validation process results in assays which meet global regulatory expectations through precise and reproducible testing. The development of each method includes thorough documentation and data integrity to achieve audit-readiness.
The team at Alturas Analytics delivers method development alongside method validation services 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 team at Alturas work together with QA personnel to develop methods which address your 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 »
The bioanalytical scientists at our organization have developed and validated hundreds of assays for different drug types and matrices.
We support:
We start each project by performing a thorough analysis of your compound 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, GC-MS, and HRMS 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. The Quality Assurance team maintains close contact with scientific staff to ensure that methods remain defensible and have complete documentation and tracing capabilities.
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 both data and confidence throughout all stages of development.
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) and 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.
Does your organization need a method development or validation service to pass regulatory reviews while supporting clinical and preclinical 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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