Dossier Services

Research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities (i.e.briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, study protocols, Patient safety narratives, Investigator Brochures, Patient information including Informed Consent and Patient Brochures, model informed consents, Pharmacovigilance documents- Periodic Safety Update Reports, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy.)