Drug Development Pathway: IND, NDA & ANDA for Pharmaceutical Product Development
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Align pharmaceutical R&D strategy with IND, NDA, and ANDA regulatory pathways to ensure compliant development and accelerate approval timelines.
By HUKSA
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
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IND Strategy in Early Development
4 Topics
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NDA Preparation and Development Alignment
4 Topics
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ANDA Development Strategy
4 Topics
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Data Management and Documentation
3 Topics
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Risk Management in Product Development
3 Topics
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Lifecycle and Post-Approval Considerations
3 Topics
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Case Study and Development Simulation
3 Topics
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Meet Your Instructor
Deep-domain, High Precision L&D - delivered directly by Renowned Industry Practitioners HUKSA
238 Course
25 Student
Offered by Huksa, this L&D program is led by elite industry veterans—CXOs and Functional Heads with 25+ years of deep-domain expertise. You have the flexibility to customize the curriculum, select your preferred expert, and align the program to your organization’s specific objectives. Connect with the Huksa team to explore our array of top-tier trainers available for this course!
₹120,000.00
This course includes:
- Lessons 8
- Topics 27
- Duration 2-3 Days
- Quizzes 0
- Language English
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