Drug substances

Nuvisan provides comprehensive chemical development and preclinical chemistry services for early-phase supply of drug substances. With extensive expertise in route scouting and developing scalable, innovative, sustainable, safe and robust processes, our teams support the biotech, pharmaceutical, veterinary and cosmetic industries from lab to GMP kilo-lab manufacturing for toxicological and clinical studies. We specialise in handling and manufacturing intermediates and active pharmaceutical ingredients (APIs), including highly potent compounds and controlled substances. 
Lab book representing few chemical structures with a pen used to draw them

Route scouting and process development

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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Green flower with chemical structure of codeine showing impurity synthesize activity

Highly potent and controlled substances

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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Female scientist working to replace a column with opened HPLC apparatus

Impurity profiling

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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Lab technician is handling a product in the XRPD apparatus

Solid-state characterisation

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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Two lab-coated technicians work in a kilolab—one at a reactor's base, the other adjusting a ventilation tube

Manufacturing

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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Contact us

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Email us

hello@nuvisan.com

Talk to us

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+49 731 9840 0 

Our locations

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Neu-Ulm (headquarters)

Wegenerstrasse 13

89231 Neu-Ulm

Germany

Berlin

Muellerstrasse 178

13353 Berlin

Germany

Sophia Antipolis

2400 route des Colles

06410 Biot

France

Grafing

Am Feld 32

85567 Grafing

Germany

Waltrop

Im Wirrigen 25

45731 Waltrop

Germany

For concerns about pharmaceuticals or adverse drug-related events, contact us at: complaints@nuvisan.com