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.