eCTD & CTD Preparation & Submission Course 2026

Explore module 1 of eCTD and CTD, detailing region-specific administrative and product information, including forms, cover letters, labeling, GMP certificates, and applicant details, with a focus on FDA 356 requirements.

Understand the common technical document framework for Europe, Japan, and the United States. It covers the five modules, regional administrative information, and quality summaries under harmonized guidelines.

Learn to craft a quality overall summary for CTD modules, detailing drug substance and product, manufacturing processes, critical controls, and cross-referenced studies.

Learn the model three quality requirements for drug substances, including nomenclature, structure, properties, and manufacturing controls, plus impurities, specifications, and analytical validation.

Explore the quality section 3.2.B for drug product: description and composition, dosage form, reconstitution, excipients, and container closure. Learn about pharmaceutical development, manufacturing process controls, stability, and related appendices.

Explore quality aspects of drug product development, including drug substance and excipients, formulation development, compatibility, polymorphism, dissolution, stability studies, and CTD/eCTD submission considerations.

Examine quality-focused drug product development in eCTD/CTD, covering formulation and manufacturing parameters, release mechanisms, stability, packaging, microbiological attributes, and compatibility with diluent and delivery devices.

Stability studies determine how long a drug product retains quality under defined storage conditions and container closure systems, using real-time, accelerated, and long-term testing to establish shelf life and labeling.

Explore the nonclinical study model, covering pharmacology, pharmacokinetics, safety and toxicology reports from animal studies, and learn regulatory tabular formats like Purdy's for nonclinical reports.

Learn to prepare and organize clinical study reports within the eCTD/CTD framework, including module 5 contents, tabular listings of studies, and pharmacokinetic, pharmacodynamic, and safety reporting.

Explore how to prepare and submit clinical safety reports in eCTD/CTD formats, detailing study report components, templates, and pharmacokinetic, efficacy, and safety parameters.

learn about the electronic common technical document (ectd) as the standard for regulatory submissions to the US, Europe, and Japan, including formatting and document management.

Explore the eCTD structure, XML backbone, and five models (M1–M5) that organize content and technical specifications for regulatory submissions across regions.

Explore how to prepare and submit eCTD using regulatory software, including login, create submission, enter description and submission type, choose five administrative models, assemble sections, upload documents, and validate.

Learn how the FDA's electronic submission gateway (ESG) provides a centralized, secure entry point for electronic regulatory submissions, automating acknowledgments, routing, and notifications while supporting eCTD workflows.

Learn the five-step FDA registration process for electronic submissions, from applying for a test account to production submissions, including account approvals, testing, and handling production readiness.

Prepare for FDA ESG registration by completing six preparatory steps, starting with submitting the non-repudiation agreement on company letterhead with a handwritten signature.

Learn how to obtain and use a digital certificate for secure eCTD submissions, including public-private key pairs, digital signatures, and non-repudiation guarantees.

Explore FDA center guidelines for electronic submissions, including how to format documents, use the ESG, apply digital signatures, and note no paper copies are required.

Adopt safe naming practices for files, directories, and digital certificates by using letters, numbers, spaces, and underscores, and avoid forbidden characters such as slash, backslash, and colon.

Evaluate the FDA ESG web interface and AS2 gateway-to-gateway to determine the best submission method for your organization, considering cost, setup, user friendliness, submission types, and network timing.

Learn to navigate the FDA ESG web interface for electronic submissions, from setting up a web trader test account to production submissions, tracking, and acknowledgements.