Alturas Analytics operates as a reliable bioanalytical CRO (Contract Research Organization) that provides precise, regulatory-compliant data for drug development programs. The company provides support for small molecule compounds across the entire research process from preclinical studies to clinical trial execution.
Our commitment to scientific excellence, together with fast response times, makes us the preferred choice for biotech and pharmaceutical sponsors.
Our goal is to provide drug developers with regulatory-grade data, which we deliver quickly while maintaining full transparency and scientific integrity. Alturas Analytics supports drug developers at every stage from first-in-human studies to pivotal trials through its experienced team and advanced tools, which help speed up the approval process.
Alturas Analytics provides complete bioanalytical services for drug development, starting from method development through final data submission.
Our scientists work in close partnership with clients to:
The company recognizes the importance of reliable results, so it actively identifies potential risks to prevent delays and maintain top-quality standards.
Alturas Analytics has extensive expertise spanning over 25 years in determining the quantity of numerous compounds.
Small Molecules: Alturas has extensive experience in small-molecule bioanalysis across multiple therapeutic fields, including oncology and CNS disorders. Our laboratory specializes in analyzing compounds that present difficult pharmacokinetic profiles and poor solubility and stability characteristics.
The unique challenges faced by biotech companies include working with lean teams while managing fast timelines and changing priorities.
Alturas Analytics provides:
Our organizational structure enables fast adaptation while maintaining continuous communication with stakeholders, including project managers and pharmacologists and regulatory leads.
The state-of-the-art LC-MS/MS and HRMS/MS instrumentation at Alturas Analytics delivers ultra-sensitive and selective results with high reproducibility.
Our in-house technology includes:
Our analysts possess expertise in method development and validation for single or multiple analytes, metabolites, and biomarkers. Our team achieves strong signal-to-noise ratios for low-level detection in difficult matrices, including tissue homogenates and cerebrospinal fluid.
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.
Our organization has consistently delivered successful submissions to both the FDA and other worldwide regulatory agencies. Our clients depend on us to:
Our organization consistently impresses in sponsor audits and regulatory inspections which gives our clients peace of mind when data quality stands as an absolute requirement.
Explore our insights: Perspectives on the ICH M10 Guidance
Clients value our:
We establish enduring partnerships through mutual accountability and dedication to excellence. The entire relationship receives clear, consistent, and caring treatment at Alturas Analytics regardless of the program complexity.
Learn how we prepare for modern 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.
Request a Bioanalytical CRO Consultation
Ready to accelerate your drug development program with a dependable partner?
Request a consultation to speak with an Alturas Analytical 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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