Electronic submissions have become the norm in the pharmaceutical industry. Electronic Common Technical Document (eCTD) is one of the most common formats used for regulatory submissions. However, there is another format that is still in use – Non-eCTD Electronic Submissions (NeeS). This essay explores NeeS and its significance in the regulatory submission process.
What are NeeS?
NeeS is a format for electronic submissions that are not in eCTD format. This format was introduced before eCTD and is still used in some regions. NeeS is typically used for submissions that don’t require the same level of granularity and detail as an eCTD submission.
What is the structure of NeeS?
NeeS submissions consist of folders and documents. The structure of a NeeS submission is not as complex as that of an eCTD submission. The submission is typically in organization by folders and sub-folders that contain the documents in requirement. Each document has a filename that is descriptive of its contents.
What are the advantages of using NeeS?
One of the advantages of using NeeS is its simplicity. Unlike eCTD submissions, NeeS submissions are less complex and easier to create. This makes NeeS submissions ideal for small companies or companies with limited resources.
Another advantage of NeeS is that it does not require the use of specialized software. Companies can use their existing software to create NeeS submissions. This reduces the cost of creating a submission and also makes it easier to maintain.
What are the challenges of using NeeS?
One of the challenges of using NeeS is its lack of standardization. Unlike eCTD submissions, NeeS submissions are not standardized. This means that each regulatory authority may have its own requirements for NeeS submissions. This can make it difficult for companies to create a submission that meets the requirements of multiple regulatory authorities.
Another challenge of using NeeS is that it can be difficult to navigate. Unlike eCTD submissions, NeeS submissions do not have a hyperlinked table of contents. This can make it difficult for regulatory authorities to navigate the submission and find the required documents.
What is the future of NeeS?
NeeS is still in use in some regions, but it is gradually replacing by eCTD. As more regulatory authorities adopt eCTD, the use of NeeS will decline. However, it is important to note that NeeS will continue to be used for submissions that do not require the same level of detail as an eCTD submission.
Non-eCTD Electronic Submissions (NeeS) are an alternative to eCTD submissions. NeeS is a simpler and more cost-effective format for electronic submissions. However, NeeS does have its challenges, such as lack of standardization and difficulty in navigation. As regulatory authorities adopt eCTD, the use of NeeS will decline, but it will still be relevant for submissions that do not require the same level of detail as an eCTD submission.
- Compliant with 21CFR part 11 regulations, we use pre-defined templates for sequence creation.
- Our approach to sequence creation involves selecting the appropriate template based on the submission request, such as SFDA, EU, or ROW Health Authorities (HA).
- Our submissions are designed to be audit-ready, with document-level formatting that adheres to the guidelines of the relevant HA.
- To ensure high quality, we perform multilevel quality checks and review before sharing or dispatching the submission to the client or HA.
- We validate the dossier and rectify any errors incurred during the compilation of the submission.
- Our approach to document allocation and simplification streamlines the submission process for improved efficiency.
- We follow 21CFR part 11 regulations and utilize pre-designed templates for creating sequences.
- Depending on the submission request, we choose the appropriate template for sequence creation, such as SFDA, EU, or ROW Health Authorities (HA).
- We prepare audit-ready submissions by formatting documents according to the guidelines of the respective HA.
- Our rigorous quality control process involves multilevel checks and reviews to ensure accuracy before sharing the submission with the client or HA.
- Our environment is designed to be flexible, easy to manage, and highly secure for Non-eCTD Electronic Submissions.
- We maintain a repository of templates for increased efficiency in document creation.
- Our team has extensive expertise in global NeeS requirements and NeeS submissions.
- We utilize automated PDF renditioning to create high-quality documents quickly and efficiently.
- Our environment provides flexibility, ease of management, and enhanced security measures.
- We offer a template repository to streamline the document creation process.
- Our team has in-depth knowledge of NeeS requirements and specializes in NeeS submissions worldwide.
- We leverage automation to generate PDF renditions and create table of contents to meet submission standards.
- Our environment prioritizes flexibility, manageability, and security for optimal performance.