Good ANDA Submission Practices
About Course
This online course provides a comprehensive guide to preparing and submitting high-quality Abbreviated New Drug Applications (ANDAs) to the US FDA.
Participants will learn the key requirements, regulatory expectations, and best practices for successful ANDA submissions, ensuring compliance with current Good Manufacturing Practices (cGMP) and relevant guidelines.
This course will highlight strategies to avoid common deficiencies, with the goal of minimizing review cycles and accelerating ANDA approval.
Who Should Enroll:
- Regulatory affairs professionals
- Pharmaceutical scientists and formulators
- Quality assurance and compliance personnel
- CRO and CMO professionals involved in generic drug development
Course Format:
- Self-paced online modules
- Lifetime access
- Quizzes & certification upon completion
Course Content
Patent and Exclusivity
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Basic Information
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Documentation and Notification of a Legal Action Filing
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Resolution or Appeal of a Legal Action
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Notice of a Paragraph IV Certification
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Pre Assessment-1
Product Quality
Bioequivalence
Labeling
Final Assessment
Earn a certificate
Add this certificate to your resume to demonstrate your skills & increase your chances of getting noticed.
Student Ratings & Reviews
This is very good and straight forward
fantastic
Good course, short and brief enough to understand.
Very informative
Perfectly detailed course
A very needy course for regulatory affairs and R&D professionals.