Alturas Analytics is a bioanalytical CRO (contract research organization) that provides precise and informative regulatory-compliant data to support drug development programs. As a specialized bioanalytical services provider, Alturas supports development across the full research lifecycle, from preclinical studies through clinical trial execution, including a refined expertise in small molecules.
Our commitment to scientific rigor, regulatory alignment, and responsive execution makes Alturas a trusted partner for biopharmaceutical sponsors.
We deliver regulatory-grade bioanalytical data prioritizing speed and transparency, while maintaining the highest scientific integrity. Alturas supports drug developers at every stage, from target discovery and early preclinical assessments, through first-in-human studies and onto pivotal trials, enabling accelerated timelines while maintaining confidence in data quality and regulatory readiness.
Alturas Analytics provides full-service bioanalytical support for drug development, spanning method development, validation, sample analysis, and final data submission.
Our scientists work in close partnership with clients to:
Alturas recognizes the importance of reliable results, so we actively identify potential risks to prevent delays and maintain top-quality standards for every sponsor.
Alturas Analytics provides comprehensive bioanalytical services to support drug development from early discovery through regulatory submission. We use practiced capabilities to generate reliable, regulatory-ready data across a wide range of compounds, study types, and analytical challenges.
Alturas develops and validates bioanalytical methods tailored to reliably and quantitatively assess each compound’s specific characteristics, ensuring accuracy, sensitivity, and reproducibility across study conditions. Our team supports both exploratory method development and fully validated assays aligned with regulatory requirements.
Alturas performs exemplary quantitative analysis using validated platforms. This includes widespread use of advanced LC-MS/MS and HRMS to deliver ultra-sensitive and selective detection of compounds within complex and challenging biological matrices. Our in-house systems and automated workflows support consistent, high-throughput analysis while maintaining strong signal-to-noise ratios for low-level detection. With best-in-class quantitative sample analysis conducted in compliance with GLP and GCP, Alturas works tirelessly to deliver audit-ready data that supports IND, NDA, and global regulatory submissions.
Bioanalytical services at Alturas can be closely integrated with our in-house pharmacokinetic (PK) and toxicokinetic (TK) analysis department to provide a complete understanding of drug exposure. This integrated approach provides a more thorough set of services for sponsors, enabling more consistent data interpretation, improved study efficiencies, and comprehensive support for regulatory submissions.
Alturas delivers submission-ready data packages supported by transparent study design and collaborative analytical approaches. Our team ensures all data meets regulatory expectations while maintaining clear communication with sponsors and study partners throughout the process.
Alturas Analytics has vast expertise from over 25 years of quantifying numerous compounds.
We have extensive experience in small-molecule bioanalysis across multiple therapeutic areas, including oncology and CNS disorders. Our laboratory specializes in analyzing compounds that present difficult pharmacokinetic profiles and/or poor solubility and stability characteristics.
Working with lean teams while managing fast timelines and changing priorities is challenging in any innovative industrial sector. Emerging biopharmaceutical products and evolving biomedical R&D capabilities have distinct complexities beyond the already challenging timelines inherent to competitive and innovative programs.
Alturas Analytics supports innovation:
Our zero-silo organizational structure enables fast adaptation while maintaining continuous communication with sponsors. We keep project managers, pharmacologists, regulatory leads, and any additionally needed experts in the loop to keep timelines on track, or even put them ahead of schedule.
Learn More: Confidence in Motion: Delivering High-Quality Bioanalysis on Time
Alturas Analytics utilizes advanced LC-MS/MS and LC-HRMS/MS instrumentation to deliver highly sensitive, selective, and reproducible bioanalytical results across complex biological matrices.
Our in-house mass spectrometry capabilities include:
Our analytical scientists possess expertise in method development and validation for single or multiple analytes, metabolites, and biomarkers. Through careful, regulatory-compliant experimental design our team achieves strong signal-to-noise ratios for high selectivity and sensitivity in difficult sample matrices, including tissue homogenates, cerebrospinal fluid, or aqueous/vitreous humor.
These capabilities allow Alturas to support best-in-class bioanalytical studies where precision and reproducibility are critical, including low-concentration detection, complex matrix analysis, and studies requiring high selectivity across multiple analytes.
Read More: Alturas Analytics’ In-House Technology
Alturas Analytics provides dependable data for IND-enabling studies and multi-site global trials. We specialize in:
The bioanalytical teams at Alturas possess deep knowledge about clinical and nonclinical operations and can adapt when new data or dosing protocols become available.
Alturas Analytics has consistently delivered data used in successful submissions to both the U.S. FDA and other worldwide regulatory agencies; Alturas also has direct experience working with the FDA. Our clients depend on us to:
Alturas Analytics consistently impresses in sponsor audits and regulatory inspections, giving our clients peace of mind when data quality is an absolute requirement.
Explore our insights: Perspectives on the ICH M10 Guidance
Sponsors value our:
We establish enduring partnerships through mutual accountability and dedication to excellence. Alturas Analytics dedicates clear, consistent, and caring treatment throughout the collaboration regardless of the program complexity.
Learn how to prepare for remote sponsor audits: Remote Audits for the Bioanalytical Lab
We operate under a robust quality management system with documented SOPs, audit-ready practices, and staff trained in GLP/GCP regulations. Our labs routinely undergo sponsor and regulatory inspections.
We analyze a wide variety of matrices including plasma, serum, urine, CSF, whole blood, and tissue homogenates. Our methods are optimized for matrix compatibility and low-level detection.
Turnaround depends on study complexity but generally ranges from 6 – 12 weeks. We prioritize communication and transparency to ensure alignment with your timelines.
Bioanalytical services required for IND submission typically include method development and validation, sample analysis, and generation of PK/TK data to support dosing and safety evaluation. These services must meet regulatory standards and provide reliable, reproducible data for submission.
Method development involves designing an analytical approach to detect and quantify a compound in biological samples. Method validation confirms that the method meets regulatory requirements for accuracy, precision, sensitivity, reproducibility, and robustness.
Bioanalytical data provides insight into drug exposure, pharmacokinetics, and safety, helping sponsors make informed decisions about dosing, formulation, and study design. Such data is essential for advancing compounds through preclinical and clinical development.
LC-MS/MS is widely used in bioanalysis because of its high sensitivity, selectivity, and ability to quantitatively detect low concentrations of compounds in complex biological matrices. It is considered the gold standard for quantitative bioanalytical testing in drug development.
Ready to accelerate your drug development program with a dependable partner?
Request a consultation to speak with an Alturas Analytics subject matter expert about your bioanalytical study needs. Let’s collaborate on a solution built for your compound, your timeline, and your goals.
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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