Health Assistance Services How can you help my company become FDA compliant?

Compliance with FDA regulations in reporting adverse events can be costly and time consuming. To fulfill its mission, our call center is “FDA inspection ready.”  We implement and maintain best practices to ensure that our processes will successfully and accurately manage your adverse events reporting.

Our services include:

  • Identification, documentation and classification of adverse events
  • Preparation and submission of expedited reports to health authorities
  • Preparation and submission of post-marketing periodic safety reports

Our Drug Safety department is trained and staffed to handle all spontaneous literature and stimulated adverse event reports.

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"I can rest easy knowing that our Adverse Drug Events are handled with care and expertise by AXA Assistance"

Current pharma client

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