Regulatory Support

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Regulatory Strategy/US Agent

  • Stira Pharma represents international and US companies as their designated US/Regulatory Agent. We interact with FDA on our clients’ behalf and provide regulatory support.

Briefing Documents and FDA Meetings

  • Prepare meeting requests, background documents, and meeting minutes for Sponsor meetings with Health Authorities.
  • Facilitate Sponsor Meetings with FDA.

Electronic Submission Support

  • Complete electronic submission capability to meet the global eCTD initiative.
  • The eCTDs published by Stira Pharma are reviewer friendly; we incorporate effective hyperlinks rather than excessive hyperlinks.
  • Stira Pharma maintains an account on FDA’s Electronic Submission Gateway (ESG) to provide our clients with worry-free delivery of electronic submissions to FDA.

Chemistry, Manufacturing & Controls (CM&C) Technical Support

  • Critical review and/or preparation, technical writing, and assembly of:
    • CMC sections for human and veterinary investigational and marketing applications filed to Global Health AuthoritiesDocumentation in support of generic drugs (ANDAs)
    • Sterilization validation documentation for sterile products
    • Drug Master Files
  • Respond to CMC-related submission queries from US and Global Health Authorities.