Pharma & Lifesciences

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

0 (0 reviews) Techno-Functional

Align pharmaceutical R&D strategy with IND, NDA, and ANDA regulatory pathways.

By HUKSA (Multiple Trainers)

Last updated February 19, 2026

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Price

Free

This comprehensive 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

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Drug Development Lifecycle from an R&D Perspective 3 Topics

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Discovery to commercialization roadmap

Translating research into clinical development

Integration of CMC, clinical, and regulatory functions

IND Strategy in Early Development 4 Topics

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Preclinical study planning

CMC data requirements for IND

Clinical protocol design considerations

Safety and documentation readiness

NDA Preparation and Development Alignment 4 Topics

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Clinical data generation strategy

CMC scale-up and validation alignment

Risk-benefit evaluation

Common R&D pitfalls during NDA submission

ANDA Development Strategy 4 Topics

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Generic product development framework

Bioequivalence study design

Formulation and process optimization

Patent and exclusivity considerations

Data Management and Documentation 3 Topics

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Common Technical Document (CTD) structure

Development report compilation

Traceability and data integrity

Risk Management in Product Development 3 Topics

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Identifying development risks

Mitigating data gaps

Cross-functional communication strategies

Lifecycle and Post-Approval Considerations 3 Topics

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Scale-up challenges

Change management during development

Continuous improvement after approval

Case Study and Development Simulation 3 Topics

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Mapping R&D activities to submission milestones

Identifying data gaps in a mock submission

Strategic development planning exercise

Meet Your Instructor

HUKSA (Multiple Trainers)

156 Course

12 Student

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This course includes:

Learners 0 Students
Lessons 8
Topics 27
Duration 6-17 Hours
Quizzes 0
Language English

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