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Drafting and submission management of PSUR, PBRER, PADER, Clinical Overview and DSURs: Comprehensive Pharmacovigilance Service packages for ROW region
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Drafting and submission management of PSUR, PBRER, PADER, Clinical Overview and DSURs: Comprehensive Pharmacovigilance Service packages for ROW region

Drafting and submission management of PSUR, PBRER, PADER, Clinical Overview and DSURs: Comprehensive Pharmacovigilance Service packages for ROW region:

Safety reports are an essential tool in the safety evaluation throughout the life cycle of a medical product. A safety physician, a person for pharmacovigilance, a data management team, a regulatory team, and medical writers aid in the preparation of a PADER. After the first marketing authorization approval is received by a MAH, the reporting cycle starts. The first quarterly PADER needs to be presented within 30 days. PSURs are deemed important pharmacovigilance documents by the authorities, and they are subject to extreme scrutiny at the time of inspection in the EU. The regulations PSUR Pharmacovigilance are complex, and effective for multiple products. At Atop Pharma Solutions, our consultants and staff have years of experience writing periodic safety update reports, planning PADERs, and DSURs cost-effectively, whether it is a single simple DSUR or PADER or complex PSURs, we can meet the requirement.