Founded in Germany, NUVISAN and its team of over 1,000 highly qualified staff believe in offering all relevant GxP services from one source to support clients in clinical development. “We want to develop into an ‘all from a single source’ provider not only for the big players in the pharmaceutical industry but also for innovative biotech companies and research institutes,” says Dr. Dietrich Bruchmann, CEO and managing partner of NUVISAN. Its range of drug development services includes API synthesis, formulation development, early clinical trial, pharmaceutical, bio-pharmaceutical, bioanalytical services, stability testing, and clinical trial manufacturing and packaging. The research organisation aims at providing its clients with all possible GxP services needed for clinical trials, which reduces the cost needed to outsource aspects of the drug development process to numerous suppliers.
NUVISAN Pharma Services: From the Molecule to the Patient
The pharmaceutical development services of NUVISAN provide stability studies at all stages of pharma product development and test both small and large molecule during pharma production. The company also provides a production facility for solid pharmaceutical products, which ranges from powder and granulation handling to the manufacturing of tablets and capsules. Each and every process carried out during pharmaceutical development takes place in Class-A rated cleanrooms.
Another noteworthy service offered by NUVISAN is primary packaging and distribution. The packaging covers the industry standards in solid, semi-solid, and liquid bulk forms, along with blisters, sachets, tubes and syringes. The organisation also provides radioactive and isotope labelling, certificate of analysis, repurification, and storage. Meanwhile, the distribution department of the CRO is operated by GDP (Good Distribution Practices) authorised personnel, who is responsible for the return and destruction of products that are surplus to requirements.
NUVISAN’s research unit for First-in-Human (FIH) trials is one of Europe’s largest and features over 100 beds for overnight stays and 40 beds for intensive assessments. Treatment can only be tested in-house under strict conditions on animals before progressing to FIH trials. The firm is also the first CRO in Europe to provide a coupled method of capillary electrophoresis, electrospray ionisation, and mass spectrometry, which helps identify and analyse proteins.
The NUVISAN group has six sites in Germany and France, in addition to monitoring activities with offices in Argentina, Brazil, and the U.S. Since its origin in 1979, NUVISAN has kept thriving on innovation, collaboration, and excellence, with only one aim that seeks to support clients at all the stages from discovery to entry in clinical development.