Our Services

Texin Global Consulting, LLC provides the following services:

• Regulatory Strategy in clinical/nonclinical/CMC

  • Development-Phases I through Phase III and Phase II/III

  • Post Approval-PMR/PMC

• FDA’s Expedited Programs

  • Accelerated Approval,

  • Breakthrough Therapy Designation,

  • Priority Review,

  • Fast Track

• Health Authority Meetings

  • INTERACT

  • Pre-IND

  • Type C

  • EOP2

  • Pre-NDA/Pre-BLA

  • Scientific Advice

• Electronic Submissions - Project Management

  • Initial IND and Amendments

  • Initial NDA/BLA and Supplements

• Pediatric Study Development (iPSP & PIP)

• Orphan Drug / RMAT Designation Applications

• Label/Ad/Promo Reviews

• TMF Support and eICF Conversion

• Regulatory Project Management

• Due Diligence

• Regulatory Intelligence

• Creating Regulatory Procedures

• Training/Mentoring Junior Regulatory Staff