Infographics | WAYS Pharmaceutical Services

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INFOGRAPHICS

Everything You Need to Know - At a Glance

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The Lifecycle of an eCTD Leaf

We break down the four eCTD lifecycle operators (New, Replace, Append, and Delete), showing how each affects a submission and how to avoid common compliance pitfalls.

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Submission-Ready PDFs for eCTD
A quick guide to creating clean, compliant, submission-ready, and reviewer-friendly PDFs for eCTD based on FDA guidance and industry best practices.

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File Formats for FDA Submissions
A brief guide to the expanding list of file formats accepted by the FDA.

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Key eCTD Milestones
A little bit of recent background and history about the current version of the eCTD.

Preparing for Your First IND - FAQs
Answers to important questions you need to consider when preparing for your first IND.

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The eCTD Basics: Structure, Submission, and Validation
This infographic describes the eCTD modules, the submission process, and the benefits of the FDA Validator rules.

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US Module 1 for a Marketing Application in eCTD Format
Check out our brief overview of the components for Module 1 of a marketing application in eCTD format.

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Six Questions to Ask a Potential Submission Management Partner

Review the 6 important questions you should ask a potential submission management partner.

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30 Years of PDUFA
Learn about the history of PDUFA, what it is, and the latest updates.

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Requesting an IND Number

See the differences between FDA CDER and CBER processes for requesting an IND number.

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Ad Promo Submissions: Preparing for the eCTD Mandate

Learn more about the June 24, 2021 deadline for ad promo submissions.

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