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Pharmacovigilance – Global aggregate report development

GAP has a qualified team of aggregate safety physicians that work with you to prepare global regulatory aggregate reports on continuous basis per regulatory guidelines. The GAP group has the expertise in both pre and post marketing drug safety regulations, worldwide market authorization applications, variations and renewals and carefully developed due diligence systems. GAP can design and lead all global regulatory report generation and submission services in alignment with electronic or paper submissions. Various documents provided under these services are PSUR, PADER, PBRER, ASR and DSUR.

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