Drug Development Pathway: IND, NDA & ANDA for Pharmaceutical Product Development

Align pharmaceutical R&D strategy with IND, NDA, and ANDA regulatory pathways to ensure compliant development and accelerate approval timelines.

This training program provides a structured understanding of the drug development pathway with focus on IND, NDA, and ANDA from an R&D perspective. It connects preclinical research, clinical development, CMC strategy, and regulatory documentation to ensure smooth progression from discovery to commercialization. Participants will gain clarity on aligning development activities with submission requirements.

Course Content

Drug Development Lifecycle from an R&D Perspective 3 Topics
IND Strategy in Early Development 4 Topics
NDA Preparation and Development Alignment 4 Topics
Data Management and Documentation 3 Topics
Risk Management in Product Development 3 Topics
Lifecycle and Post-Approval Considerations 3 Topics
Case Study and Development Simulation 3 Topics
Meet Your Instructor
₹120,000.00
Add to favorite Added to favorite
This course includes:
  • Lessons 8
  • Topics 27
  • Duration 2-3 Days
  • Quizzes 0
  • Language English
Share
Report
Search
Courses

Please enter keywords