Topic: Pharma Dossier Preparation (eCTD & ANDA)

Introduction:

Pharmaceutical dossier preparation is a critical component of regulatory affairs, involving the systematic compilation and submission of scientific, technical, and administrative data required for drug approval. With the global shift toward harmonized regulatory practices, the electronic Common Technical Document (eCTD) has become the standard format for regulatory submissions across major authorities such as the USFDA, EMA, and other ICH member countries.

The Abbreviated New Drug Application (ANDA) is a key regulatory pathway in the United States for the approval of generic drugs, requiring demonstration of bioequivalence, quality, and compliance with regulatory standards. Pharma dossier preparation for eCTD and ANDA ensures that pharmaceutical companies present their data in a structured, compliant, and review-friendly manner, thereby facilitating efficient regulatory evaluation and market authorization.

Scope:

The scope of Pharma Dossier Preparation (eCTD & ANDA) encompasses the end-to-end process of compiling, formatting, validating, and submitting regulatory dossiers in accordance with international guidelines. It includes:

• Understanding the structure and modules (Module 1–5) of the eCTD format
• Preparation of Quality (CMC), Non-clinical, and Clinical sections
• ANDA-specific requirements including bioequivalence studies and labeling
• Document lifecycle management and electronic publishing tools
• Regulatory guidelines from ICH, USFDA, EMA, and other global authorities
• Validation, submission, and post-submission activities such as amendments and responses to queries

This domain plays a crucial role in global drug registration, lifecycle management, and regulatory compliance.

Objectives:

The primary objectives of learning Pharma Dossier Preparation (eCTD & ANDA) are to:

• Develop a clear understanding of eCTD structure and submission workflow
• Gain expertise in preparing ANDA dossiers for generic drug approval
• Understand regulatory requirements and guidelines for global submissions
• Learn document formatting, hyperlinking, bookmarking, and validation processes
• Acquire knowledge of electronic submission tools and publishing software
• Enhance the ability to manage regulatory submissions efficiently and compliantly
• Prepare for careers in regulatory affairs, dossier publishing, and submission management

Who can enroll:

This course/module is suitable for:

• B.Pharm, M.Pharm, Pharm.D students and graduates
• Life sciences graduates (Biotechnology, Microbiology, Biochemistry, etc.)
• Professionals working in pharmaceutical industries (QA, QC, Production, Regulatory Affairs)
• Individuals aspiring to build a career in Regulatory Affairs and global drug submissions
• Freshers seeking entry into pharma regulatory, documentation, and dossier publishing roles
• Professionals aiming to upskill in eCTD publishing and ANDA submission processes