IND Submissions

PSC Clinical promotes quick FDA review and faster market placement for your product with the goals of its IND Submissions service. With intimate knowledge of the FDA submission review requirements, PSC’s consummate staff can:

  •  Advise on requirements and format
  • Assist preparation of data to support your application
  • Prepare, assemble, and review the required documents and reports

 

The expert team at PSC Clinical specializes in the following regulatory submission deliverables:

  • Investigator brochures, study protocols, and protocol amendments
  • Pre-IND and –NDA meeting briefing packages
  • IND/Investigational Device Exemption (IDE) applications and period safety updates
  • Clinical study reports
  • Patient narratives
  • Pre-market notifications 510(k)
  • 505(b)(2) submissions
  • Biologic License Applications (BLAs)
  • Integrated Summaries of Safety (ISSs) and Integrated Summaries of Efficacy (ISEs) in eCTD format
  • Safety updates, annual and 120-day post-submission reports

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