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AMRI's experts work directly with regulators to participate in standard setting activities for ISO 10993-18 & ISO 10993-17

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Unither analytical services include methods development & validation, analytical methods transfer, ICH stability studies with storage, extractable & leachable closure system compatibility studies, unknown substance identification & characterization etc .

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West offers extractables/leachables analysis for packaging and delivery systems for all pharmaceutical and biological products.

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AMRI offers 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 & overall packaging configuration of your product.

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Unither analytical services include methods development & validation, analytical methods transfer, ICH stability studies with storage, extractable & leachable closure system compatibility studies, unknown substance identification & characterization etc .

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

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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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Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.

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With a nationwide network of 29 environmental laboratories, 3 life sciences labs, 2 LabOps locations, and 46 service centers, Pace Analytical offers compendia (USP, EP, JP) methods of analytical services for qualitative and quantitative assessment of raw materials, APIs and Finished Products.

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Our scientists conduct extractables and leachables studies in accordance with Good Manufacturing Practices (GMPs) ,PQRI recommendations, United States Pharmacopeia (USP) requirements.

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Our extractables and leachables analytical services include: Modify and validate controlled extractable methods for testing and profiling of leachables and Develop HPLC, GC, and MS methods for controlled extractables from pharmaceutical containers, closures and devices.

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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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Genotoxicity of the impurity can be evaluated based on FDA approved software. It offers genotoxic and Potential extractable and leachables studies and stablishment of Specification and acceptance criteria

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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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At Saneca Pharma, we offer a range of generic API development services including route of synthesis optimisation. Our API development & manufacturing facilities use the same equipment to take your project from pilot to commercial scale production.

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Physical and physio-chemical determinations (e.g. pH,nconductivity, viscosity, melting point, refractometer, polarimeter, sub-visible particle counter, osmolality, loss on drying)

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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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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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Analytical research and development (AR&D) offers standalone services and supports our formulation development activities.

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DPT’s provides reliable and accurate analytical testing services for Extractable & Leachables.

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Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness

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We offer Integrating Capabilities of Building product safety into process design under one roof, which can facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitgating risks associated with the final product.

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DPT’s provides reliable and accurate analytical testing services for Impurities.