Global eCTD Publishing and Submission Services

Global eCTD Publishing and Submission Services

The use of electronic Common Technical Document (eCTD) has become a universal standard for the submission of regulatory documents to Health Authorities worldwide. Global eCTD publishing and submission services play a vital role in helping pharmaceutical companies achieve a smooth and successful regulatory submission process.

Understanding eCTD

The eCTD is a digital format for the submission of regulatory information for medicinal products. It comprises of a standardized folder structure and file naming conventions. The aim of the eCTD is to improve the efficiency of the regulatory submission process and reduce errors.

eCTD Requirements

  • The requirements for eCTD submissions differ among Health Authorities.
  • For instance, the US FDA mandates that all new drug applications (NDA), abbreviated new drug applications (ANDA), and biologic license applications (BLA) be submitted in eCTD format.
  • In Europe, eCTD format is compulsory for all centralized procedure applications.
  • The use of eCTD format in submission requirements can vary between Health Authorities.
  • To comply with the US FDA’s guidelines, NDA, ANDA, and BLA submissions must be in eCTD format.
  • For centralized procedure applications in Europe, eCTD format is a mandatory submission requirement.
  • Health Authorities may have different expectations regarding eCTD submissions.
  • eCTD format is a submission requirement that varies by region and Health Authority.
  • If submitting an NDA, ANDA, or BLA to the US FDA, eCTD format is mandatory.
  • In Europe, all centralized procedure applications must be submitted in eCTD format, as per Health Authority requirements.

Benefits of eCTD

The use of eCTD provides many benefits over traditional paper-based submissions. Firstly, eCTD submissions are more efficient, reducing the time and cost associated with paper-based submissions. Secondly, the eCTD allows for easier tracking and management of submissions. Finally, the eCTD provides a more secure method of submitting regulatory documents, with less risk of documents being lost or damaged.

Global eCTD Publishing Services

Global eCTD publishing services help pharmaceutical companies to prepare and submit eCTD applications for regulatory approval. These services can include the creation of eCTD submission-ready documents, publishing of the eCTD, and the management of the submission process.

Document Creation

The creation of submission-ready documents is a critical part of the eCTD publishing process. Global eCTD publishing services provide support in the creation of documents such as clinical study reports, investigator brochures, and product labeling. The documents are created according to the required format and structure for eCTD submissions.

Publishing and Compilation

Once the submission-ready documents are created, they are compiled into the eCTD format. Global eCTD publishing services can provide support in compiling the documents into the required structure and format. They also ensure that the documents comply with the necessary technical requirements for the submission.

Submission and Lifecycle Management

Global eCTD publishing services also offer support in the submission of the eCTD to Health Authorities. This includes managing the submission process, ensuring that the submission is complete and accurate, and following up with the Health Authority to ensure that the submission is acceptable. Additionally, they provide ongoing support throughout the lifecycle of the submission, including the maintenance of the eCTD.

Global eCTD publishing and submission services have become an essential part of the regulatory submission process for pharmaceutical companies worldwide. With the increasing demand for eCTD submissions, it is crucial to work with a partner that has the expertise and experience in preparing and submitting eCTD applications. The use of global eCTD publishing services can provide pharmaceutical companies with a more efficient and streamlined regulatory submission process, reducing costs and improving the chances of successful regulatory approval.

Templarpharma Expertise in Global eCTD Publishing and Submission Services

  • We establish and maintain a process for documenting regional Health Authority (HA) requirements.
  • Our team can convert paper-based submissions to Non-eCTD electronic submissions (NeeS) or eCTD formats as needed.
  • We develop a knowledge repository to capture regional requirements across the globe.
  • Our team provides periodic training and updates on changing global Regulatory requirements.
  • We conduct gap analyses to identify areas where process aids, charts, and other resources can help.
  • We monitor projects continuously to ensure they remain on track and on time.
  • Our team conducts periodic quality checks to ensure effective time management.
  • We create detailed trackers to follow all version changes made throughout the publishing lifecycle.
  • We use Templarpharma SUBMIT PRO, an in-house Regulatory publishing and submissions eCTD tool.
  • Our services include capturing and documenting regional HA requirements, converting paper-based submissions to electronic formats, maintaining a knowledge repository, providing training and updates, conducting gap analyses, project monitoring, quality checks, version tracking, and using our proprietary Regulatory publishing and submissions eCTD tool.

Templarpharma Advantages

  • Our team consists of highly qualified experts in publishing and submission.
  • We use a robust eCTD publishing and submissions software to support our services.
  • Our eCTD submission roadmap covers everything from initial submission compilation to lifecycle maintenance.
  • We offer support for regulatory resource allocation.
  • Our services include both report-level and document-level publishing.
  • We provide error-free submissions, allowing your organization to focus on core business functions.
  • Our two-stage quality check process and 24/7 global delivery model ensure transparency and quick turnaround times.