Medical Writing

Azidus provides medical writing services such as: Development of protocol, informed consent form (ICF) and case report form (CRF) development, preparation of clinical report, analytical report and statistical report, adverse event and concomitant medication reporting using m=MedDRA and WHO-DD dictionaries, preparation of FDA summary tables for ANDA submissions, development of medical investigational reports, regulatory affairs reports, preparation of annual safety reports, individual case safety reports, periodic safety update reports, preparation of preclinical study reports, investigational medicinal product dossiers, toxicology reports, submission of IND and ANDA applications.