Advantages of eCTD
Managed correctly, eCTD format brings huge benefits to a pharmaceutical company of any size.
- One ‘place of truth’ – quickly and unambiguously determine what is currently registered for a particular product, facilitating the implementation of IDMP in 2016.
- Instant Submissions – eCTD sequences can be transferred to agencies via specialist electronic portals and so can be available to the assessors within a matter of hours.
- Global Strategy – with the growing global acceptance of eCTD, applications can be submitted in multiple countries with relatively minor changes resulting in huge cost savings over the lifetime of a product.
TRAC has an experienced and dedicated team of publishing experts who have built over 500 successfully validated sequences and will work with you to deliver your project within your time frames.
Our numerous years of practical experience cover all types of submissions ranging from initial Marketing Authorisation Applications (MAAs), Active Substance Master File procedures, renewals, periodic safety update reports (PSURs), variations, response to questions, and consolidation sequences, covering all EU and national procedures.
- Ad hoc or Long-term Needs – TRAC will build initial sequences or can quickly and easily upload existing sequences on to our software system, to continue the lifecycle management of products that have already transferred to eCTD, if you are looking to change providers or plug a temporary internal resource gap.
- Supporting the Transition to eCTD – TRAC have specialist skills in converting existing licences from NeeS or paper format to eCTD format. When you decide to progress to eCTD we can work with you to create a Baseline Sequence; a compiled submission of the current status of the dossier. Baseline submissions are strongly recommended in the EU and mean you can take full advantage of the lifecycle tracking element of eCTD.
- Understanding of Lifecycle Maintenance – all of our publishers have CMC authoring experience and understand the likely changes a product will see over its lifecycle. This means we can collaborate with your regulatory team to offer advice on the authoring and structure of your dossier to ease the burden of future updates, creating sequences that will stand the test of time.