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

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

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.

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.

Synthesising & Characterising Impurities

Analytical >> Extractables and Leachables >> Impurity Isolation and Identification

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.

Leachables & Extractables Studies

Analytical >> Extractables and Leachables >> Testing Services

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

Leachable Method Development, Validation & Monitoring

Analytical >> Extractables and Leachables >> Testing Services

From residual solvents and process-related impurities to extractables/leachables and degradant-related impurities, Eurofins BioPharma Product Testing offers a broad range of services in support of impurities testing.

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.

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.

Extractable & Leachable Studies

Analytical >> Extractables and Leachables >> Testing Services

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