Commonly known as NeeS is abbreviated as Non-eCTD Electronic Submission. NeeS in paper format became mandatory in European Union since 2003. Similar to eCTD, NeeS should follow the document granularity as structure according to International Conference of Harmonization (ICH) guidelines. Though, NeeS is not identical to eCTD as it differs through navigational structures. XML backbone or Table of Contents, like in eCTD, is not used in NeeS. Electronic metadata and Module 5 security are also not included in NeeS. ICH specifies the filename and regional filenames should be named carefully as it may lead to technical validation errors.
When a new drug is manufactured, an invented name is given along with its various dosage forms and its strengths. This information is given in NeeS. For other subsequent submissions also the same structure should be used. Electronic Table of Contents is used for the whole document in NeeS. NeeS uses module by module structure. During the review process, document bookmarks and hyperlinks are used in NeeS. The product types comprise of small molecules, vaccines, homeopathic, herbal, bioproducts and blood products.
Tammina Life science Expertise :
There are some general submissions considerations and Tammina Life science life science experts makes sure they follow them. Our company helps you to travel through Regulatory documentation compilation. A submission is basically a collection of files which is maintained in separate files by Tammina Life science. We make sure the total folder path should not cross 180 characters which are the limit. Tammina experts use afour-digit number in the folder where ctd-toc.pdf is placed. The rules for placement of document name as eCTD. We take care that the document should be submitted in the appropriate place with a compiled view of information over time. The electronic information, provided by Tammina experts,is readable and usable to National Command Authorities’ (NCA’s) hardware and software. The NeeS document is provided in PDFs always from Tammina.
Why Tammina Life science :
- Tammina Life science has its pre-defined templates.
- Tammina Life science has an expertise in NeeS requirements.
- Based on the submission request we use templates for creating the sequence.
- Submissions are audit-ready in Tammina Life science.
- Quality checkups are done at many levels and before dispatching or sharing the submission Tammina Life science experts review once.
- Simplification and allocation of documents are done by Tammina Life science life science regulatory experts.
- Suffering during submission compliance like Error rectification, validation of documents is taken care of by Tammina regulatory experts.
- Tammina Life science believes in giving you the assurance that we do documentation which is very easy to manage and at the same time flexible and quick to learn too.
- Tammina Life science NeeS experts create a required table of contents and automate rendition of PDFs.
- Usually, NeeS drawback is its security, unlike eCTD. Tammina Life science NeeS experts assure your company that you will have a very secure and accurate documentation.
- As all documents are stored in the same repository, NeeS files are very simple to manage.
- Tammina Life science NeeS experts believe in the simple way of managing the documents like drag and drop into a structure.