Re-invention of existing molecules has become an important aspect of drug development. Whether it is development of a fixed dose combination, a new administration route or a new indication for a well-known substance, re-invention can bring benefit to patients. The development work for re-invention might need a full set of tests, or it might be possible to refer to literature for some of the development work, e.g. toxicology information on the substance or previous experience in the indication.
Due to extensive experience in fields of clinical and pharmaceutical development as well as profound knowledge of registration procedures the experts of DADA are able to evaluate the feasibility of its client’s development projects, both re-invention projects and for standard development. DADA experts research literature to establish what is known and, connecting that to the regulatory requirements, indicate what still needs to be performed in order to compile an adequate marketing authorisation application. The feasibility report prepared by DADA expert team provides meaningful suggestions on pharmaceutical development, on clinical aspects and on a most suitable regulatory strategy.