In order to keep up with the latest developments in the field of cGMP regulated biopharmaceutical analytics, NUVISAN has added several Mass Spectrometry (MS) techniques to its repertoire.
Nuvisan Pharma Service is a contract research organisation with decades of experience in pharmacological and pharmacokinetic studies, delivering a comprehensive range of solutions for clinical trials.
All services can be customised to meet specific project requirements. Solutions include non-clinical studies, analytical labs, clinical trials, pharmaceutical solutions, and supplies for clinical trials.
Clinical trial supply services
As Nuvisan can provide all the necessary capabilities required for clinical trial supplies, this leads to increased simplicity and reduced costs. This also means that there is no need to outsource aspects of the drug development process to numerous suppliers.
Stability studies are carried out at all stages of the pharma product lifecycle. The company provides both small and large molecule testing services for pharmaceutical production, which are all supported by state-of-the-art systems in highly automated laboratories.
Nuvisan Pharma Service
The company’s CTS unit is able to offer a wide spectrum of production services for solid pharmaceutical products. These range from powder and granulation handling, to the manufacturing of tablets and capsules. Services can also be provided for semi-solids and non-sterile liquids.
All processes take place in Class A-rated cleanrooms.
Pharmaceutical development solutions
Nuvisan offers an extensive range of services for primary packaging, covering the industry standards in solid, semi-solid, and liquid bulk forms, as well as blisters, sachets, tubes, and syringes. Printing is also provided for labels, inserts, and outserts.
GDP-authorised personnel operate Nuvisan’s distribution department. Controlled and monitored storage areas span from room temperature units to walk-in refrigerators and freezers. The distribution department can also take full responsibility for returns and destruction of products that are surplus to requirements.
Nuvisan has the capacity to perform LC/MS bioanalysis by highly qualified lab personnel using advanced UHPLC-MS/MS equipment.
Drugs and metabolites can be measured down to pg/mmL levels in circulation, as well as in bodily fluids and tissues
In addition, Nuvisan is able to offer radioactive and isotope labelling, comprising synthesis, certificate of analysis (CoA), repurification, storage, and all the necessary equipment.
First-in-human trials services and facilities
Treatments can be tested in-house under strict conditions on animals, before progressing to first in human (FIH) trials should they prove successful.
The FIH unit is one of Europe’s largest and features 100 beds for overnight stays and 40 beds for intensive assessments. Alongside this, treatment rooms can be modified in order to meet specific requirements.
Please get in touch using the form on this page with your requirements and Nuvisan will be able to provide customised solutions to meet specific demands.
Nuvisan Pharma is pleased to announce that it is hosting a live talk on turning complex analytical workflows into LC / MS biomarker assays on 11 February at 10-11am local time.