Our process development begins with lab-scale evaluation, encompassing safety, scalability, optimisation, purification and solid-state analyses. Our scientific team possesses extensive expertise in chemical process development, with a strong focus on solid-phase characterisation and impurity profiling.
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Nuvisan can produce highly potent active pharmaceutical ingredients (HPAPIs) up to an OEL of 0.1µg/m³, from gram scale to multi-kilo quantities, within a GMP environment. Nuvisan can also import, synthesise and analyse controlled substances, including opioids, cannabinoids, narcotics and psychoactive drugs.
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The identification and structural elucidation of impurities is a routine requirement in process development. Nuvisan’s highly experienced scientists can isolate, identify, synthesise and assess unknown impurities present at very low levels (<0.1 %). Our chemists can identify degradation pathways and potential ingredient interactions that will facilitate the examination of dossiers by regulatory agencies.
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Nuvisan's highly experienced scientists can readily assist you in selecting and controlling the solid state of your API. Nuvisan conducts solid-state investigations of small organic molecules to identify new solid forms, such as polymorphs, salts, co-crystals or amorphous forms. These studies can provide a deep understanding of the solid state of your intermediate or your API.
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Advance your candidate from preclinical through phase 1 clinical studies with Nuvisan's scale-up services. Our state-of-the-art facilities, boasting a total capacity of 266 litres across 300 square metres, enable the production of kilogram-scale batches for clinical studies.
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