Generics
To collaborate in the development of generic pharmaceutical products is a prioritary service rendered by Kymos Pharma Service, a service clearly booming in businesses like ours. At an analytical level, we carry out most of the studies required for registering a new generic drug.
We are giving comprehensive analytical support to generics-making companies. Basically, the analytical services rendered include: a) the first pre-formulation phases, where characterisation of both the reference product and the active principle to be used is necessary; b) study of different formulations until reaching the final formulation, and c) manufacture of pilot batches, including development and validation of the definitive analytical methods to be used for batch release and for the stability studies. Also, we perform comprehensive stability studies and comparative dissolution studies of solid oral generic formulations associated with the reference formulations (in vitro bioequivalences).
On the other hand, we take on us the bioanalytical portion of the bioequivalence clinical studies. With such purpose we develop and validate analytical methods in accordance with the regulations in force, and with those methods we analyse the plasma samples from clinical studies at very reasonable prices, in accordance with resource optimisation required by the development of a new generic drug.
