FDA Regulatory Submissions
About This Course
This course gives you everything you need to successfully navigate FDA regulatory submissions for pharmaceutical products. Whether you're preparing your first IND, NDA, or BLA, or looking to improve your submission success rate, this course breaks down complex regulatory processes into clear, actionable steps. You'll learn exactly what documents you need, when to submit them, and how to communicate effectively with FDA reviewers. We cover real-world examples and common pitfalls so you can avoid costly mistakes. By the end, you'll have the confidence and knowledge to prepare complete, compliant submissions that get approved faster. This isn't just theory—you'll get practical templates, checklists, and strategies you can use immediately in your work.
What's Included
Course Format
Self-paced, on-demand learning with lifetime access. Complete at your own speed with no deadlines.
Key Topics Covered
What You'll Learn
- Understand FDA regulatory pathways for pharmaceutical products
- Prepare and submit IND, NDA, and BLA applications
- Navigate FDA communication and review processes
- Develop regulatory strategies for product development
- Master document preparation and submission requirements
Course Outcomes
By the end of this course, you will be able to:
- Prepare complete IND, NDA, and BLA submissions
- Navigate FDA review processes confidently
- Develop effective regulatory strategies
- Communicate effectively with FDA reviewers
- Understand post-approval requirements
Who Should Take This Course
- Regulatory affairs professionals
- Pharmaceutical product managers
- Quality assurance specialists
- Clinical research coordinators
- Anyone preparing FDA submissions
Prerequisites
- Basic understanding of pharmaceutical development
- Familiarity with regulatory terminology
Course Content
Module 1: Introduction to FDA Regulations
- FDA structure and regulatory framework
- Key regulations: CFR Title 21
- Regulatory pathways overview
Module 2: IND Applications
- IND requirements and structure
- Pre-IND meetings
- IND submission and maintenance
- Clinical hold procedures
Module 3: NDA Submissions
- NDA application types
- Documentation requirements
- FDA review process
- Post-approval commitments
Module 4: BLA Submissions
- Biologics regulatory framework
- BLA vs NDA differences
- CMC requirements for biologics
- Biosimilar pathways
This course is delivered through Thinkific. You'll receive access instructions after enrollment.