Trac Services | eCTD Service - TRAC
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TRAC as your eCTD Outsourcing Solution

The consultancy for global, pharmaceutical regulatory affairs

At TRAC, we understand finding a trustworthy partner can sometimes be a headache, although we like to think our many years of experience, and satisfied clients, demonstrate TRAC is a company you can trust. We have been creating eCTD submissions since 2008 and have the systems and processes in place for all your eCTD and NeeS publishing needs.

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

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.

Read our report – 2016: The Year of eCTD Preparation

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.

“I run a small regulatory consultancy without eCTD publishing capabilities and have outsourced regulatory work and publishing to TRAC for nearly 5 years now. The service TRAC provides is exemplary. I have confidence the individuals involved with processing and publishing my submissions are not just administrative staff but have in depth regulatory knowledge and therefore can add value to the overall service I provide to my clients. The project planning capabilities, execution and deliverables on e-CTD publishing are first class, at competitive rates. I have no hesitation recommending TRAC to any of their potential clients.”

Regulatory Affairs Consultancy Owner

Benefits of Outsourcing

Many companies outsource their eCTD publishing as a cost and time effective solution to the many issues associated with internal implementation of eCTD.

  • Pay-as-you-go Service – no large outlays in time or money. The arduous process of choosing, installing and configuring of publishing software is not required. Costs associated with equipment, software maintenance, and training staff are removed and if the service is not up to standard, changing provider is quick and easy.
  • Flexible and Dedicated Capacity – no resource gaps. Immediate access to a dedicated resource with tried and tested ways of working in place to increase efficiencies and ensure a published dossier is delivered on time.
  • Skilled Workforce – experienced resource at your fingertips. Tap in to the working knowledge of a team that are highly trained and able to quickly resolve all manner of validation issues.
Talk to TRAC about your eCTD requirements