Teleios Analytical Services is a provider of laboratory testing and expert regulatory advisory services for Pharmaceutical and Medical Device companies — supporting every stage from discovery through lifecycle management.
"Every test we do in perfection while keeping up the patients' health and safety to provide quality products."
We offer all testing needs during discovery, characterization, product development, drug & medical device approvals, and lifecycle management.
Supporting product development of INDs, NDAs, and ANDAs with comprehensive characterization testing.
Robust analytical techniques for pharmaceutical products, medical devices, dietary supplements, and cosmetics.
Our experienced team develops robust analytical techniques through review of chemistry of intermediates, raw materials, drug substances, packaging materials, and drug product formulations using Quality by Design principles.
We support analytical method validations and/or verification as per ICH, USP, EMA, and other regulatory requirements — covering prescription and OTC pharmaceuticals, medical devices, dietary supplements, and cosmetics.
Evaluating Single Use Systems (SUS) and manufacturing process components.
Manufacturing processes use components partly or fully constructed from plastic polymeric materials — commonly Single Use Systems (SUS). These components contact manufacturing process streams from starting materials through the finished drug product.
Such contact can lead to the release of extractables (PERLs) that persist in the process stream, accumulate in the drug product, and potentially affect product quality and patient safety.
Teleios' experienced team evaluates your process components, assesses associated risks, proposes controls, and prepares a complete risk assessment report in compliance with USP<665>, USP<1665>, or BOPG Best Practices guidance.
End-to-end E&L study design, execution, and toxicological risk assessment.
Extractables are substances that can be extracted from pharmaceutical packaging materials, biomedical devices, or drug delivery systems. Leachables migrate from container closure systems under normal use conditions — typically present at trace levels but posing significant risk to patients.
Our team designs, develops, and executes forced Extractable studies using a stepwise approach — considering the intended final use and Maximum Daily Dose (MDD) — and generates complete data with toxicological risk assessment in line with USP and ICH regulations.
Highly sensitive nitrosamine testing compliant with FDA, EMA, and ICH M7 guidelines.
Nitrosamines are potent genotoxic impurities that require careful monitoring across pharmaceutical products. Our advanced instrumentation allows detection and quantification at the lowest possible levels — well below regulatory acceptable intake limits.
We provide full NDSRI (Nitrosamine Drug Substance-Related Impurities) testing, risk assessment, and regulatory-ready reports aligned with evolving FDA and EMA requirements.
Trace-level detection aligned with ICH M7 and regulatory thresholds of toxicological concern.
Genotoxic impurities present unique analytical challenges due to the very low levels at which they must be controlled. Our LC-QTOF and GC-MS/MS platforms enable sensitive, specific detection of potential genotoxic compounds in drug substances and drug products.
We provide method development, validation, and testing per ICH M7 with full documentation suitable for regulatory submissions.
High-resolution mass spectrometry–driven structure elucidation of unknown peaks.
When unexpected impurity peaks appear in your chromatograms, Teleios provides comprehensive characterization using our high-resolution LC-QTOF platform for accurate mass measurement and structural elucidation.
Our scientists combine non-targeted analysis, database searches, and chemical reasoning to identify unknowns and provide risk-based assessments — enabling informed decisions about your manufacturing process and product quality.
Container closure system testing for compatibility, safety, and regulatory compliance.
Packaging materials must be rigorously tested to ensure they do not compromise product quality or patient safety. Teleios performs comprehensive testing of primary and secondary packaging components, including glass, plastics, rubber closures, and combination products.
Our testing programs are designed to meet USP <232>, <467>, <665>, and ISO 10993 requirements, with full documentation for regulatory submissions.
Our customers are our strength, and our customer goals are our goals. We combine state-of-the-art instrumentation with direct scientist-to-client communication — eliminating the bottlenecks common in large CROs. Whether you're a biotech startup or global pharma, Teleios scales with you.
Advanced LC-QTOF, GC-FID/MS, and ICP-MS instrumentation. Direct scientist-to-client communication eliminates delays and interpretation gaps.
Full adherence to FDA, EMA, ICH, USP, and ISO guidelines — minimizing risk and accelerating your market entry at every stage.
Flexible solutions for startups and large pharma alike — from early-phase formulations through commercial production.
Our target is to provide regulatory compliance reports that meet FDA, EMA, and ICH requirements — ready for submission without rework.
From emerging biotechs navigating first IND filings to established manufacturers managing complex global supply chains, Teleios provides the analytical depth your regulatory strategy demands.
Teleios brings specialized expertise, cutting-edge instrumentation, and a compliance-first mindset to every engagement. Reach out and we'll get back to you promptly.
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