A spin-off from the University of Liège
Nucleis is a spin-off from the University of Liège (Cyclotron Research Center - Belgium) created to outsource the GMP manufacturing and distribution of PET (Positron Emission Tomography) radiopharmaceutical drugs.
The company was created in June 2017 with the transfer of the business unit (team, pharmaceutical certifications, CMO (Contract Manufacturing Organization) contracts and dedicated manufacturing facilities) from CRC (Cyclotron Research Center) and benefits from over 15 years of experience.
Our mission is helping with your diagnostics
The company core-business consists in the manufacturing of Market Authorised drugs and Investigational Medicinal Products. Nucleis is also a key partner for CMO activities.
Nucleis is the MAH (Marketing Authorisation Holder) and Manufacturer of a FDG (Fludeoxyglucose (18F)) MA (Marketing Authorisation) granted in Belgium, The Netherlands, Luxembourg, France and Germany. Furthermore, as part of our CMO activities, Nucleis is registered as Manufacturer in several MA granted among EMA (European Medicines Agency).
Our products
Nucleis aims at developing a wide portfolio of diagnostic tools in order to support the emergence of innovative therapies.
Dedicated to PET
Nucleis is a radiopharmaceutical company, created in June 2017 and has performed a transfer of the business unit (existing team, pharmaceutical certifications, CMO contracts and dedicated manufacturing facilities) from CRC in November 2017 and benefits from over 15 years of experience.
Nucleis is a spin-off from the University of Liège (CRC-Cyclotron) created to outsource the GMP manufacturing and distribution of radiopharmaceuticals drugs dedicated to Positron Emission Tomography (PET).
Develop direct sales
Nucleis propose direct sales among Nuclear Medicine department, equipped with a PET-Scan, with Glucotrace (FDG) marketed in Belgium, Netherlands, Luxembourg, France and Germany and also with other drugs with an Investigational Medicine Product dossier (clinical trial).
In addition to its own portfolio, Nucleis performs “Contract Manufacturing Officer” activities with several companies like GE Healthcare or Blue Earth Diagnostics. This CMO activity concerns radiopharmaceutical drugs with a Marketing Authorization (MA), like VizamylTM (Alzheimer disease) or AxuminTM (prostate cancer), and also drugs with a IMP dossier (Investigational Medicinal Products) like 18F-Flurpiridaz (Hearth diseases).
Certifications
Nucleis holds the following GMP certifications and manufacturing authorisations from the Belgian Federal Agency for Medicines and Health Products (FAMHP). Furthermore, Nucleis is the Marketing Authorization Holder (MAH) and manufacturer of Glucotrace (Fludeoxyglucose (18F)) granted in Belgium, The Netherlands, Luxemburg, France and Germany.
GMP Certificate n° BE/GMP/2018/061 for Human Investigational Medicinal Products
MIA 1932 H
GMP Certificate n° BE/GMP/2018/060 for Human Medicinal Products
MIA 1932 IMP
Working together for the best results
We are delivering our products and services to customers in 5 countries.
- Belgium
- France
- Germany
- Netherlands
- Luxembourg
