Start-up Services / Regulatory Submissions

JDP works with sponsors and investigators in preparing regulatory dossiers. We have a very good understanding of the regulatory environment and what it takes to ensure expedited approval process in order to meet protocol timelines. We ensure adequate logistics and personnel are available for a study take off. We develop document templates and logs including, informed consent forms, SOPs, delegation logs, case report forms, training logs, screening and enrolment logs, investigator site file, trial master file, among others for studies. We facilitate the importation of study materials and investigational products. We again offer translation services.