Scientific Applications
We specialize in product development, CMC services, Q1/Q2/Q3 deformulation, impurity and unknown chemical/material identification & quantification, product failure analysis, advanced product testing, litigation support services, and innovation.
Life Sciences
Biologics Analysis
Bioanalytical characterization services support candidate R&D, regulatory submissions, and beyond.
Therapeutic Peptide Analysis
Our team can expertly handle a variety of peptide analysis studies including degradation, stability, purity/potently assessment, and more.
Therapeutic Protein Characterization
We offer a suite of protein analysis services including enzymatic assay development, kinetic testing, and post-translational modification determination.
Monoclonal Antibody Characterization
Access products from this fast-growing biologic class with our cellular potency/efficacy assessments, glycosylation determination, impurity detection, and more.
Gene Therapy Analytical Testing
Enable critical efficiencies throughout gene therapy process development with services geared towards reliably accessing vector quality at all stages.
Biosimilar Testing Services
As the Biologics market matures further, biosimilar development efforts will continue to ramp up. Avomeen’s testing services can support your biosimilar development projects and 351(K) applications.
Cell Culture & Cell-Based Bioassay Services
Avomeen’s cell-based bioassay expertise is at your disposal for advanced drug characterization, potency assay development, cellular response data, lot release support, and more.
COVID-19 Diagnostic Test Development Laboratory
Vital public health and vaccination efforts need accurate diagnostics. Get full-service support for your SARS-CoV-2 diagnostic development project.
Bioanalytical Testing Services & Capabilities
Find a broad range of advanced bioanalyses to support your preclinical and clinical research.
Bioanalysis & Clinical Biomarker Services
Readily detect and measure relevant biomarkers and understand drug performance with our bioanalytical method development, validation, and execution services.
DMPK & ADME Support
From selecting a candidate with an appropriate ADME profile to monitoring its bioavailability throughout clinical trials, our team provides full-service DMPK support.
Toxicity & Clearance Assays
Ensure product safety with independent expert assessments of in vitro cytotoxicity, preclinical toxicology, and clearance assay bioanalyses.
CMC Consulting & Lab Services
Regulatory & scientific experts provide robust, regulatory-driven, phase-appropriate services to help you achieve the full potential of your drug compound.
Extractables & Leachables Testing
Test pharmaceutical products for extraneous chemicals and materials that migrate from manufacturing equipment, packaging, and delivery devices.
Impurity Analysis & Identification in Biopharmaceuticals
Isolate and identify any impurities or unknown compounds in finished biopharmaceutical products and raw materials.
Pharmaceutical Formulation & Process Development
Dedicated, experienced teams help guide your biopharmaceutical and therapeutic formulations smoothly through development.
Cleaning & Process Validation
Manufacture multiple biopharmaceutical products safely & cleanly on a single line.
Topical Product Development
Industry-leading topical formulations are developed by teams of Ph.D-led formulation scientists.
Photostability Testing
Improve product quality, speed to market, and verification of correct packaging and exposure for photosensitive substances.
Solid State Characterization
Selecting the optimal solid form of an API is critical to the success of a formulation.
Compendial & Non-Compendial Testing
Regulatory & scientific experts provide compendial & non-compendial testing to ensure compliance and support regulatory submissions.
Preformulation Services
Investigate the chemical and physical properties of pharmaceuticals.
Quality by Design (QbD)
This systematic approach ensures a higher-quality product, and the FDA looks for the use of a QbD approach in submissions.
Small Batch Manufacturing
GMP-compliant rapid small-batch manufacturing delivers needed materials on your timeline.
Elemental Impurities Testing
Comply with metals impurities standards according to USP 232 & 233.
Pharmaceutical Drug Batch Release Testing
Our teams have a proven record of success in developing, validating, and transferring complex and challenging analytical methods for batch release.
GMP Clinical Trial Manufacturing
Our teams produce and deliver dosage forms for clinical trials under GMP conditions on your timeline.
Full Program Support
Our full support program is designed to bolster your product’s integrity and see your drug development from inception to the post-approval phase.
Pharmaceutical Stability Testing
Stability-indicating method development & validation, forced degradation & full stability programs per ICH guidelines.
Chemicals & Materials
Stability & Shelf Life
Ensure your products and pharmaceuticals meet shelf life and stability standards.
Competitor Analysis
Obtain an in-depth analysis of a competitive product to support patent claims, identify formulations, and more.
Food Contact Notification
Evaluate the risk of contamination posed by materials that come in contact with food.
Quality Control
Bring your products and pharmaceuticals up to predefined standards with chemical analysis.
Impurities, Unknown, & Contamination ID
Uncover the chemicals in your products and substances that are causing contamination.
Litigation Support Services
Back evidence and testimony with scientific knowledge & consultation.
REACH Compliance
Maintain compliance to REACH regulations with chemical characterization & risk assessment.
Extractable & Leachable Studies
Keep extraneous materials and chemicals away from and out of sensitive products.
Method Development & Validation
Get help creating repeatable & reliable methods for various validations.
Materials Testing
Understand the chemistry of a material – identification, purity, properties, and more.
Product Development
New Product Development Services
Our team of industry-leading product formulators specialize in innovative product development.
Green & Eco-Friendly Product Development
The need for environmentally friendly products will only continue to grow. See how our experts can apply an eco-friendly approach to product development.
Product Reformulation
Reformulate your product into a new and improved version with our next-gen reformulation laboratory.
Product Performance Testing
Test to regulatory, domestic, international, and industry standards, as well as retailer, or individual technical requirements.
Reliable Results
Clients come to Avomeen when they need an innovative next-gen product formulation developed that meets their exact specifications and is completed on their time-frame or when they have a complex product or chemical analysis need that requires accurate/reliable results. We offer quick turn-around times on all of our projects and quotes, a friendly staff that is truly on your side, talented chemists led by experienced Ph.D. project leaders, and state-of-the-art analytical instrumentation.
Can we help you complete even your most complex product development or material testing project? Yes we can!
Let’s work together to achieve your vision.
Request a quote or ask an experienced scientist today.
Let’s work together to achieve your vision
Ready to get started? Click Get a Quote, or talk to an expert first if you’d like help in defining your project scope.