eCTD Submission Guidance Hub
This resource provides comprehensive guidance on eCTD submissions. Find comprehensive info on each eCTD submission type by clicking on the information.
NDA
Submissions
Discover everything about new drug applications.
ANDA Submissions
Understand how generic drugs reach patients.
IND Submissions
Find answers to for navigating the IND application process in this guide.
BLA Submissions
We break down BLAs so that you can expedite your submission.
510(k) Submissions
Read this guide for a comprehensive understanding of the 510(k) process.
PMA Submissions
Learn how to get FDA clearance for high-risk Class III medical devices.
CTA Submissions
Discover CTA submissions and how to prepare for these.
MAA Submissions
We explore everything you need to know about MAA submissions.
Additional resources on eCTD &
Regulatory Submissions
Are you new to eCTD submissions? Here is some additional info.
What are eCTD submissions & why are they important?
eCTD is a standardized electronic format for regulatory submissions that has revolutionized the regulatory landscape. By replacing paper-based submissions with electronic files, eCTD offers numerous benefits, including:
- Efficiency: Streamlines the submission process, reducing time and costs.
- Accuracy: Minimizes errors and omissions, ensuring accurate information.
- Global harmonization: Promotes consistency across regulatory agencies.
- Environmental benefits: Reduces paper consumption and waste.
Overall, eCTD has significantly improved the speed, efficiency, and accuracy of regulatory submissions.
Types of eCTD submissions
Types of eCTD Submissions
eCTD submissions can be categorized based on their purpose or content. Here are some common types:
- New Drug Application (NDA): Submissions for new drugs that have not been previously approved.
- Biologics License Application (BLA): Submissions for biological products, such as vaccines and therapeutic proteins.
- Supplemental New Drug Application (sNDA): Submissions to amend or modify an existing NDA or BLA.
- Investigational New Drug (IND): Submissions to conduct clinical trials of a new drug.
- Annual Report: Submissions to provide updates on ongoing clinical trials or marketed products.
- Safety Update Report: Submissions to report adverse events or safety concerns associated with a product.
- Post-Marketing Surveillance Report: Submissions to monitor the safety and efficacy of a product after it has been approved.
- Resubmission: Submissions that have been previously rejected by a regulatory agency and have been revised to address the deficiencies.
These are just a few examples of the various types of eCTD submissions that can be made to regulatory agencies. The specific requirements for each submission type may vary depending on the jurisdiction and the nature of the product being submitted.
Key Components
Key Components of eCTD Submissions
eCTD submissions are organized into a structured format that consists of several key components:
- Region-Specific Modules (RSMs): These modules contain information specific to a particular regulatory region, such as the United States, Europe, or Japan. They are used to ensure compliance with regional regulatory requirements.
- Data Standards: eCTD uses standardized data formats and structures to ensure consistency and compatibility between submissions. These standards include the Extensible Markup Language (XML) and the Document Type Definition (DTD).
- Metadata: Metadata provides information about the submission, such as the product name, sponsor, and submission type. It helps regulatory agencies efficiently process and review submissions.
- Electronic Common Technical Document (eCTD) Structure: This defines the overall structure of the submission, including the sequence and organization of the various components.
- Electronic Submissions Gateway (ESG): This is a secure electronic platform that allows sponsors to submit eCTD submissions to regulatory agencies. It ensures the integrity and confidentiality of the submissions.
These key components work together to create a standardized and efficient format for regulatory submissions, facilitating the review process and improving regulatory decision-making.
We (real people) are here to answer all your questions. As long as they are about DocShifter.
DocShifter is trusted by companies of all sizes
in regulated industries
DocShifter for Life Sciences - FAQ
Does DocShifter also digitize paper documents?
No, digitizing paper documents and paper-to-digital scanning are not services we offer.
Instead, we specialize in digital documents as a starting source, converting to your choice of further digital formats.
Is DocShifter available as a true Software-as-a-Service (SaaS) platform?
No, DocShifter itself does not offer a complete SaaS service today. DocShifter is installed on-premise, in the customer’s cloud, or in his public cloud space. Why is that? Mostly the sheer volume of documents is simply to big to send back and forth over the internet. In addition, privacy is often an important reason for our customers to keep their precious documents close.
If you are interested in a true SaaS platform, running on DocShifter, please leave us a note, we can get you in touch with one of our partners.
Is there any data exchange with third-party services?
No data is exchanged between DocShifter and any other third-party entity. We value the privacy of your documents.
Where is DocShifter installed?
DocShifter can be installed:
- On premise in your own data centre.
- In your private/hybrid or public cloud.
- In Docker containers, orchestrated by Kubernetes.
- On either Windows or Linux. We realize you have a preference.
We used to lose data during conversions. How do you handle it?
DocShifter has been designed to work in regulated industries where extremely high-quality and high- fidelity results are expected. All formatting and content will be included in the results. Some configuration will be required to ensure the results are as required, and it is important to ensure that any fonts used are available (otherwise formatting may change based on the font substitutions required when a font is not installed).
In the specific case of Excel and OpenOffice Calc files, DocShifter has a number of options available to ensure any hidden information or wide sheets are formatted appropriately in the results.
DocShifter Insights (metrics and reports) provides clear visibility into the number of incoming conversion requests and the number of successful and unsuccessful results. This information can be filtered and viewed in a number of different ways. Both tabular and graphically.
How does DocShifter handle confidentiality & security?
We consider confidentiality and security to be a strategic priority within our software. The underlying software dynamics used to convert any document within DocShifter’s environment do not store any data or documents during conversion.
As conversion takes place within your hardware and/or infrastructure, DocShifter has no access to the contents of your documents. We value your privacy and have built DocShifter’s entire suite of solutions to be safe, secure and entirely confidential.
How many DocShifter Servers do I need?
A few factors can help us estimate this for you:
– Number of documents that need to be converted per day, week, etc.
– How quickly you need to receive the results.
– What repositories you are using.
– Intended infrastructure for our servers and the content (on premise, in the cloud, etc.).
– The type of content that needs to be converted.
– Whether high-fidelity / compliant conversion is necessary.
– Do you need High-Availability.
– Is a disaster recovery environment needed.
– How many different non-production environments do you use (test, development, staging, validation, training, etc.)
Please use the form above to begin these discussions.
How does DocShifter's software handle transformation errors?
A number of methods are available for tracking processing errors in DocShifter.
If a job was submitted via web services, any errors or warnings will be returned via the response message for immediate action. Different HTTP status codes are returned depending on the type of issue.
Notifications can also be configured to send alerts via email, SNMP, Webhook or to another database. These can be configured specifically for each workflow created, and different actions deployed, depending on whether it’s a ‘fatal’ or ‘warning’ error.
Error logs feature in the Administration Console for any jobs that have failed, while detailed job logs are also available to provide further detail on the cause of any issue.
Where appropriate, DocShifter’s software will attempt to retry an incomplete job, dependent on the error in question.
Does DocShifter support RESTful API?
Yes. DocShifter fully exposes its functionality via a standard RESTful API.
Does DocShifter software support optical character recognition (OCR)?
DocShifter allows for fully-automated OCR from any file format supported, which includes all image formats listed in a given RFP. The accuracy of results will depend on the quality of the image being processed via OCR, so the required 90% guarantee cannot be achieved without the quality of the content source also being guaranteed.
For more information, please visit our DS OCR software solution page.
