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Simplify the process of migrating your NeeS submissions into eCTD format
With the ever-growing requirement for eCTD across Europe it is essential that your submission data is updated and available in the standard eCTD format. According to the EU roadmap, from January 2018, eCTD will be mandatory for all Mutual Recognition Procedure (MRP) and Decentralized Procedure (DCP) submissions, and from January 2019 all submission types within National Procedures (NP) will also be required in eCTD format – some countries even earlier this date, as Germany and Denmark.
The most efficient way to migrate from NeeS to eCTD
If your submissions are currently only available in NeeS format, there is no time better than now to begin the transition process. EXTEDO's NeeS to eCTD conversion service provides you with the expertise and resources you need to convert your existing NeeS submissions into eCTD format. It saves you time and money, and allows your essential internal resources to continue with daily operational activities.
- Reduce the time and effort required to migrate NeeS formatted submissions to eCTD
- Trusted guidance from industry and standards experts
- Ensure data quality through detailed activity and adaption logs
- Guarantee quality of final eCTD submission
- All data is kept within EU borders during entire conversion process
Our team of expert consultants will work with your business to uncover any existing NeeS submissions and plan your structured migration process. Through a partially automated sequence of steps we will then convert the existing submissions into the eCTD format. Throughout this process a detailed conversion report will be maintained, this outlines all activities undertaken and any adaptions made to the submission. Once the conversion is complete, our eCTD experts will perform a final review and technical validation of each submission to ensure that it complies with appropriate regional standards.
EXTEDO's NeeS to eCTD conversion service includes the following elements:
- Import of original EU NeeS dossiers
- All activities and changes tracked and reported
- High quality conversion supported by EXTEDO's industry-leading tools
- Validation of final eCTD submission
Whether one or hundreds, if you still have submissions in NeeS format now is the time to get them converted to eCTD. EXTEDO is here to support you throughout that journey, so contact us now to find out how we make the process effortless.