Our Services

Texin Global Consulting, LLC provides the following services:

• Regulatory Strategy in clinical/nonclinical/CMC

  • Development-Phases 1-3

  • Post Approval-PMR/PMC

• Health Authority Meetings

  • INTERACT

  • Pre-IND

  • Type C

  • EOP2

  • Pre-NDA/Pre-BLA

  • Scientific Advice

• Electronic Submissions - Project Management

  • Initial IND

  • IND Amendments

  • Initial NDA/BLA

  • NDA/BLA Supplements

• Pediatric Study Development

  • iPSP

  • PIP

• Orphan Drug Applications

• Label/Ad/Promo Reviews

• TMF Support

• Regulatory Project Management

• Due Diligence

• Regulatory Intelligence

• Creating Regulatory Procedures

• Training/Mentoring Junior Regulatory Staff