Unmatched Technical Expertise
Etico Lifesciences has successfully conducted over 50+ Extractable & Leachable studies and completed numerous analytical method validations for regulatory markets worldwide. Our USFDA-registered facility operates with a zero-query track record, serving as a testament to the expertise and quality of our multidisciplinary team.
Extractable & Leachable Studies
Comprehensive assessment of potential migrants from packaging systems and medical devices to ensure safety and stability.
Genotoxic / Nitrosamine Impurities
High-sensitivity testing for nitrosamines, identified as probable human carcinogens, ensuring full compliance with global mandates.
Analytical Method Development
Strategic development and validation of stability-indicating methods tailored for niche generics and complex molecules.
Glass Delamination Studies
Evaluating glass vial integrity to prevent flake formation, crucial for ensuring the safety of parenteral injectable products.
IVRT Studies (USP <1724>)
In Vitro Release Testing for semi-solid dosage forms, facilitating bio-equivalence comparisons and formulation optimization.
Elemental Impurities (ICH Q3D)
Precise detection and quantification of toxic metal elements in drug substances and products according to global pharmacopoeias.
Rheology Studies
Advanced flow behavior analysis for complex topicals and liquids to ensure correct application and shelf-life consistency.
Compatibility Studies
Rigorous Diluent and Infusion compatibility testing to ensure stability during clinical administration and storage.
De-formulation & Q1/Q2
Reverse engineering of reference products to achieve precise sameness in inactive ingredients and concentration.
Experience Analytical Excellence
Accelerate your regulatory path with a zero-query analytical partner.
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