The skills at Seratec cover different areas, from the development of therapeutically active molecules to the supply-turnkey, with or without exclusivity, of an active pharmaceutical ingredient registered with the local Health Authorities, the EMA (European Medicines Agency ) for Europe or the FDA (Food and Drug Administration) for the US.
Development of organic chemistry procedures (synthesis, extraction, etc.) :
Seratec proposes, among other things, the design or improvement of procedures, the study of critical parameters, the isolation of key intermediates, or the control of increases of scale (scale up, from the laboratory to the industrial pilot) under contracts with pharmaceutical companies, with or without exclusivity.
The unique experience of Seratec in pharmaceutical chemistry allows it to understand exotic reagents as well as complex chemical or multiple-step syntheses.
Development and validation of analysis methods :
Once the requested product is obtained, it is necessary to control its content and to demonstrate its purity and, in parallel, the absence of potential toxic substances in compliance with the international standards set by the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), the quality reference forming the basis of GMP (Good Manufacturing Practices) in Europe and cGMP (current Good Manufacturing Practices) in the USA.
Validation of procedures (manufacturing, cleaning, etc.) and stability tests :
The registration of an active substance by us assumes that Seratec demonstrates the “validity” of its chemical manufacturing process, that is to say, the adequacy of this process in terms of the required purity, and its adequacy as to whether or not the quality of the product obtained is reproducible. This validation process requires completing at least three consecutive batches to obtain controlled qualities of materials (which in practice takes the form of a continuous process of validations by campaigns), then stabilizing these last three batches under the conditions laid down by the ICH.