Regulatory Submission (NDA)

Regulatory Submission (NDA): Master the US Drug Approval Process from CMC to FDA Review

Submitting a New Drug Application is one of the most complex regulatory undertakings in pharmaceutical development. This certified learning path, developed under the expert guidance of Dr. Patricia Kay, gives regulatory affairs professionals, CMC scientists, and submission managers the knowledge and tools to build, document, and defend an NDA that meets FDA expectations at every stage.

Course Included:

• Submitting a New Drug Application (NDA) in the USA: Navigate the complete NDA submission process — from eCTD structure and module content to FDA review timelines, complete response letters, and approval pathways.
• CMC: Chemistry, Manufacturing, and Controls: Build expertise in the CMC section of regulatory submissions — covering drug substance, drug product, analytical methods, and manufacturing process documentation required by FDA.
• Pharmaceutical Regulatory Affairs: Develop a broad regulatory strategy foundation, understanding how FDA regulations, guidance documents, and the review process shape submission planning and lifecycle management.
• Good Documentation Practice (GDocP): Apply ALCOA+ principles to all submission documents — ensuring that every record in your NDA package meets FDA data integrity standards.
• Pharmaceutical Data Integrity: ALCOA and ALCOA+: Understand the data integrity requirements that FDA inspectors scrutinise in NDA submissions and during pre-approval inspections.
• Introduction to FDA 21 CFR Part 11: Ensure your electronic records, electronic signatures, and audit trails meet the 21 CFR Part 11 requirements that apply to all electronically-managed NDA data.
• Regulatory Compliance Inspections and External Audits: Prepare your organisation for FDA pre-approval inspections — understanding inspection procedures, common findings, and how to demonstrate robust regulatory compliance.

Why Choose This Learning Path?

• Expert-Led Curriculum: Developed by Dr. Patricia Kay, a senior life sciences professional with over 20 years of experience in regulatory strategy, clinical development, and compliance management.
• Comprehensive Coverage: From eCTD structure and CMC documentation through data integrity, Part 11 compliance, and inspection readiness, this path covers every critical dimension of a successful NDA.
• Flexible Learning: Fully self-paced and online — build your regulatory submission expertise on your schedule.
• Certification: Earn a recognised certificate validating your NDA submission competency to employers, sponsors, and regulatory bodies.

Who Should Enroll?

Whether you are a regulatory affairs specialist, CMC scientist, clinical operations manager, or quality professional preparing for your first NDA or seeking to deepen your submission expertise, this learning path was built for you. It is equally valuable for pharmaceutical teams building internal regulatory affairs capabilities or preparing for FDA pre-approval inspections.

Turn Regulatory Complexity into Competitive Advantage

Join thousands of life sciences professionals who have used GxP Training to earn recognised, employer-valued certifications. In an increasingly scrutinised regulatory environment, NDA submission expertise is among the most valued skills in the pharmaceutical industry. Enroll today.