Global aggregate report development

The Ashfield Pharmacovigilance Global Aggregate Reporting group consists of a professional team of physicians and regulatory experts that work with you to assist with the continuous cycle of preparing global aggregate regulatory reporting.

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The Ashfield Pharmacovigilance team has expertise in both pre and post-marketing drug safety regulations, global marketing authorization applications, variations and renewals and carefully developed due diligence strategies. Ashfield Pharmacovigilance is able to lead all global regulatory report generation and submission services designed to align with electronic or paper submissions.

Reports delivered:

  • Global periodic safety reporting (PADER, PSUR/PBRER)

  • Provide support for ASR/DSUR

  • NDA and IND submissions (supporting preparation of IND/NDA annual reports, NDA ISS sections and clinical study reports)

  • Regulatory report submissions to appropriate authorities

  • Medication error and drug abuse/misuse reporting

  • Toxicology report management

  • Medical writing support for report generation

  • Other special reports required by regulatory authorities (e.g. risk management associated reports and other post-marketing commitments)

  • Aggregate PADER/PSUR/PBRER reporting including:

  • Tracking of reporting periods and submission dates

  • Generation of tables & listings from safety database

  • Analyze line listings and prepare relevant tables Analyze previous aggregate reports for the product

  • Compose case summaries and analysis

  • Draft report for client review and approval

  • Medical review of each report

  • We also work with you to provide ad hoc solutions for any specialized regulatory request.

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