NOVO PROVIGILANCE LLC

NOVO PROVIGILANCE covers all therapeutic medications for preparation and submission of aggregate reports (Periodic adverse drug experience report; Periodic safety update report/Periodic benefit risk evaluation report; Developmental safety update report; Annual safety reports; Clinical study reports and Analysis of Clinical Overview) with consistent quality within Regulatory timelines.

Reports are prepared by requesting raw data from the client and compiling data, author the report post data lock point. Post review of the report, it is finalized and submitted to appropriate Regulatory authority and or Competent authority. We have profound competence in preparing reports covering almost all Regulatory authorities globally.

ACO: We assist our clients in partial or complete preparation, review and finalization of the addendum to the clinical overview. The report which collects all accumulated effectiveness and safety data related to a medicinal product since MA or its last renewal, in order to obtain a new renewal for any medicinal product. It is an essential safety report to reevaluate the current benefit/risk balance, assuring patient's health and safety.