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Chemical Characterization

Analytical >> Extractables and Leachables >> Chemical Characterization

AMRI's experts work directly with regulators to participate in standard setting activities for ISO 10993-18 & ISO 10993-17, which articulate the framework for the medical device industry to meet safety testing needs through the use of analytical chemistry & biological/toxicological assessment.

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Extractables & Leachables for Pharma & Biotech

Analytical >> Extractables and Leachables >> Testing Services

AMRI offers a complete suite of extractables and leachables (E&L) testing services to assist in the evaluation of the manufacturing process, including single use systems (SUS), final container/closure, drug delivery devices and overall packaging configuration of your product.

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Impurities

Analytical >> Extractables and Leachables >> Impurities

AMRI's experts help you determine and quantify the impact of potential genotoxic impurities on drug efficacy through toxicological risk.

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Toxicological Risk Assessment (TRA)

Analytical >> Extractables and Leachables >> Toxicological Risk Assessment (TRA)

AMRI offers toxicological risk assessment (TRA) services to evaluate risks to patient health by assessing the leachates of a system against information on in vitro tests, animal studies, computational methods and predictive means.

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Extractable & Leachables

Analytical >> Extractables and Leachables >> Testing Services

Extractable and Leachables (both organic and inorganic) study in drug product. It offers development and validation of analytical methods, study stability sample for establishment of leachables maximum level, and qualification of extractable and leachables.

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Extractables & Leachables Study

Analytical >> Extractables and Leachables >> Testing Services

GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.

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Extractable & Leachable Study

Analytical >> Extractables and Leachables >> Testing Services

Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.

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Assessment of Leachables & Extractables In Drug Products

Analytical >> Extractables and Leachables >> Testing Services

Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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Extractables & Leachables analysis

Analytical >> Extractables and Leachables >> Testing Services

Boston Analytical's staff has experience evaluating Extractables & Leachables in pharmaceutical packaging, medical devices, drug-delivery/combination products, processing equipment, Single Use Systems, e-cigarettes, and consumer product packaging.

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Extractables & Leachables Testing

Analytical >> Extractables and Leachables >> Testing Services

Whether you are evaluating container closure systems, delivery devices, single-use systems or manufacturing equipment, Eurofins BioPharma Product Testing offers a broad range of services to support extractables and leachables testing.

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