We have the possibility of small scale manufacturing set up for individual customer needs, which can be used in development work of new radiopharmaceuticals, for clinical trial batches or for development of drug master files.
We can offer small scale manufacturing of APIs and intermediates for use in cold kits, for example in the area of R&D of new radiopharmaceuticals for clinical trial batches or tracers for SPECT/PET scanning for diagnosis of diseases, receptors for diagnosis or research.
- scale up synthesis, from mg to multi grams or kilos
- develop synthesis from non-GMP to GMP
- optimize the route of synthesis to the target molecule and increase the overall yield
- optimize the environmental profile of the overall synthesis
Reliable and reproducible analytical methods are essential to the quality of the products. Our analytical development services include method development and validation, stability study, GMP release of raw materials and API. We work to develop or refine existing analytical methods to meet these demands, and provide analytical validation in compliance with GMP, Ph. Eur. and ICH guidelines. Qualified instruments and experienced scientific staff ensure efficient, high-quality services.
Please contact us in order to discuss your specific needs.