What is eCTD Publishing?
Electronic Common Technical Document or eCTD Publishing is a global standard for submitting clinical trial information to regulatory authorities. It is the only internationally recognized format for the submission of clinical data and related documents, such as protocols and lab manuals.
It was developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH was founded in 1990 by the European Commission, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the United States Food and Drug Administration (FDA), Health Canada, and the European Medicines Agency (EMA).
An eCTD submission has five modules namely – region-specific information, summary documents, quality-related information, nonclinical study reports, and clinical study reports.
Who needs eCTD Publishing Services?
eCTD Publishing is an essential service for any organization that deals with the distribution of electronic documents. It ensures that the information within these documents is easily searchable, organized, and accessible by a wide range of users.
It applies to the following types of submissions to the CDER / CBER –
- NDAs
- ANDAs
- BLAs
- Commercial IND applications
- All subsequent submissions to these types of applications, including amendments, supplements, and reports. Even if your original submission was filed before the requirements went into effect, you will need an eCTD publishing for this application.
- Master files like DMFs which are considered to be submissions to an IND, an NDA, an ANDA, or a BLA.
- European Submission -MRP-DCP-Variation Type 1 or 2
- European ASMF – CEP/COS Filing
- Health Canada ANDS Submission – Master File Submission
- and many more application depending upon the country
What is the process for eCTD Publishing Services?
The eCTD publishing and submission filing consists of three main steps –
- Processing of PDF Files to Meet ICH and Regional requirements
- Publishing in eCTD format as per the country specific requirement
- Validation of Published Document to provide error free submisison
- Contact the FDA or the Electronic Submission Support team via email to inform your intent to them. The intent should be of submitting the eCTD and to enquire a pre-assigned number.
- Final Submissions to FDA or Health Authorities
How can Perfect Pharmaceuticals Consultants help in eCTD publishing?
eCTD publishing and compilation is a complex task. If not done the right way, it can directly impact your regulatory approval. With an extensive experience of 30 years and an in-depth knowledge of handling eCTD regulatory submissions, Perfect Pharmaceuticals Consultants can make this a smooth process for you.
Here we will help you publish eCTD publishing by working with you to create a strategy for your submission and then providing the technology, training, and support needed to successfully publish.
We’ll work with you to evaluate your current situation and determine what kind of support is needed. Then we’ll implement a plan to get you where you need to be. We’ll help you make sure that all of the information in your submission is accurate, complete, and consistent across all documents.
There are many challenges in life which can be solved by means of eCTD publishing. We possess the experience and knowledge to provide pharmaceutical companies with the right help. You can mostly see that there is a high number of eCTD publishing service providers but very few of them have years of experience and knowledge.