CMC

CMC (Chemistry, Manufacturing and Controls) at Nuvisan encompasses a comprehensive range of services that support pharmaceutical and biotech companies in drug development. The Nuvisan CMC team helps ensure that pharmaceutical products are manufactured consistently, safely and to the highest quality standards in adherence to regulatory requirements. 

Key areas include drug substances, where Nuvisan specialises in the synthesis, optimisation and analytical validation of active pharmaceutical ingredients (APIs). Our drug products services focus on designing robust formulations, supported by stability studies to ensure product shelf life. We provide extensive analytical pharmaceutical solutions, offering quality control and characterisation of raw materials, intermediates and finished products.  

Nuvisan’s manufacturing capabilities include small-scale and pilot-scale production under Good Manufacturing Practice (GMP)-compliant conditions, catering to preclinical and clinical trial needs. Our expertise in clinical trial supply helps ensure the efficient production, packaging, labelling and distribution of investigational products to meet trial requirements globally. Additionally, the CMC team supports clients with seamless preparation and submission of CMC sections for regulatory dossiers (INDs, NDAs, EMA filings) and readiness for audits and inspections.  

With a focus on innovation and compliance, our CMC services are integral to our ability to accelerate drug development timelines while maintaining regulatory and quality benchmarks.