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Pharmacopeial Assays

Our pharmacopeial assay service offers qualitative assessments and quantitative measurements of target entities.  We can assay drugs or biochemicals for their presence, concentration and functionality.

Our experts can identify, assay and determine the quality, purity and stability of your raw materials to be used in manufacture.  Analysis can be carried out in accordance with pharmacopoeial monographs (Ph. Eur., BP, USP and JP) and / or to your specifications.

Using a wide range of chemical analysis techniques, we provide quality control (QC) testing of raw materials, APIs, finished products, packaging materials and medical devices as outlined in marketing authorizations and pharmacopoeias.

Our experts perform GMP batch release testing to ensure your products are the highest quality of pharmaceuticals / biopharmaceuticals before sale, supply or export and to help make sure they are regulatory compliant.  Our state-of-the-art analytical facilities support testing to ensure products meet specifications within the marketing authorization (MA) or Clinical Trial Dossier (CTD).  Our dedicated service is extended beyond our laboratories with our method transfer and analyst exchange services to make sure QC procedures are smoothly integrated into your production environment.

Whatever your needs please get in touch and our team will be able to help.

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