Comprehensive service that encompasses all of the development phases of a drug until its commercialisation – by a promoter of the pharmaceutical industry- like a new coated tablet.
As it is a generic drug, it is specifically used for the treatment of malaria, rheumatoid arthritis and lupus, reducing pharmaceutical expenditure by the Healthcare System.
In this project, all of the phases of pharmaceutical development are addressed pharmaceutically: from the galenic development and definition of the manufacture process, as well as the development of the analytical techniques for the recovery, determination of the dissolution percentage and the quantification of the related substances , going through manufacture and release of the batches.
The bioequivalence study and the ICH stability study are performed in different climate conditions to determine the product’s expiry date.
This project has been developed entirely at TECNALIA, participating in its implementation: the Pharmaceutical Development Laboratory, Laboratorium Sanitatis Manufacturing Plant (LABSAN) and the Clinical Trials Unit.
