Regulatory Submission (NDA)

NDA Submission Training: Master the FDA Drug Approval Process from CMC to Approval

A single deficiency in an NDA package can cost a sponsor 10 to 24 months and tens of millions of dollars. This certified online learning path for US NDA submissions, developed under the expert guidance of Dr. Patricia Kay, gives regulatory affairs professionals, CMC scientists, and submission managers the framework, documentation standards, and inspection readiness needed to build and defend a New Drug Application that meets FDA expectations at every stage.

Learning Path:

• Submitting a New Drug Application (NDA): Navigate the full NDA 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, covering drug substance, drug product, analytical methods, and process documentation required by FDA.
• Pharmaceutical Regulatory Affairs: Develop the regulatory strategy foundation that shapes submission planning and lifecycle management.
• Good Documentation Practice (GDocP): Apply ALCOA+ principles so every record in your NDA package meets FDA data integrity standards.
• Pharmaceutical Data Integrity: ALCOA and ALCOA+: Understand the data integrity requirements FDA inspectors scrutinize during NDA review and pre-approval inspections.
• Introduction to FDA 21 CFR Part 11: Ensure your electronic records, 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 organization for FDA pre-approval inspections, including procedures, common findings, and how to demonstrate robust compliance.

Why Choose This Learning Path?

• Expert-Led Curriculum: Developed by Dr. Patricia Kay, a senior life sciences leader with 20+ years in regulatory strategy, clinical development, and compliance management.
• End-to-End Coverage: From eCTD structure and CMC documentation through data integrity, Part 11 compliance, and inspection readiness, every critical dimension of a successful NDA in one path.
• Flexible Learning: Fully self-paced and online. Build your NDA expertise on your schedule.
• Recognized Certification: Earn a CPD/CEU-accredited, 21 CFR Part 11-compliant certificate validating your NDA submission competency to employers, sponsors, and regulatory bodies.

What You’ll Be Able to Do

• Structure an eCTD submission that meets FDA technical standards.
• Author and review CMC sections to withstand FDA review.
• Apply ALCOA+ and 21 CFR Part 11 requirements across all submission documentation.
• Prepare your site for an FDA pre-approval inspection.

Who Should Enroll?

Whether you are a regulatory affairs specialist, CMC scientist, clinical operations manager, or quality professional preparing for your first NDA, or deepening existing submission expertise, this 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

GxP Training delivers certified, employer-recognized training to life sciences professionals worldwide. In an increasingly scrutinized FDA environment, NDA submission expertise is among the most valued skill sets in pharma. Enroll today and build the skills that bring medicines to market.