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Regulatory Affairs

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EGeen regulatory affairs services provide critically accurate review, submission and approval capabilities from both beginning to end of the clinical trial. From national and regulatory body relationships to proper filings, EGeen ensures that the value capture of the clinical trial data results in positive product outcomes and approvals.

Regulatory Relationships

  • Ethics committee interactions, relationships
  • Regulatory approval requirements
  • National authorities relationships
  • Data submissions to regulatory authorities

Investigational Product Importation

  • Product registration
  • Product importation and shipping logistics

Pharmacovigilance

  • SAE reporting, audits

Regulatory Administration

  • Document translations
  • Submission file design and compilation