eCTD Submissions Excellence: Case Studies & FAQs

Wherever you are on your regulatory journey, turning content into a fully compliant, navigational eCTD submission can feel like standing at the bottom of a mountain.  This blog provides case studies on how we assist clients with limited resources and summarises common FAQs applicable to each scenario.

Bespoke Regulatory Operations Solutions: Case Studies

Case Study 1: Little to No Experience with Regulatory Operations

Situation

We are a small life sciences company approaching our first IND filing.  We cannot invest in an eDMS or Publishing software, and our knowledge of the regulatory operations framework is limited.  How can DLRC Regulatory Operations help?

Solution

From the offset, planning is key alongside practical advice on regional expectations and specification guidance.

Our advanced software investment gives us a high advantage for efficient compliance checks and the addition of navigational aids.  A robust Submission Content Plan captures the collaborative efforts of a QC review. Once finalised, delivery to the FDA via the most appropriate platform is set.

Case Study 2: Good Understanding of the Regulatory Operations Requirements

Situation

We are a medium-sized pharma company and can provide eCTD-compliant PDF files. However, we have no in-house publishing software and cannot maintain access to the regulatory authority submission platforms. The aim is to file an MAA to the EMA.

Solution

Appointing a Lead publisher to support every project team with operational strategy accelerates the preparation process. A regional content plan is critical to the collaborative sharing of information for authors, reviewers, and publishers, providing complete status visibility.

Case Study 3: Highly Experienced in the Regulatory Operations Arena

Situation

We are a large pharma company with our own regulatory operations group, but we need extra resources to help us get our application across the line for a limited period.

Solution

Working with an external project team across global sites to maximise the workday expands knowledge and time for QC review. With internal tracking and communication tools, proven processes and systems highlight and mitigate risk, enhance publishing expectations, and instantly display publishing status.

Navigating Common Concerns: FAQs in Regulatory Operations Support

We give clients supportive direction. To better understand the challenges we help our clients overcome, we have considered the most frequently asked questions received in our daily interactions with clients.  These encapsulate the most common concerns or risks you may want to consider that apply to many operational and application sizes.

What if our documents are later than the agreed delivery timelines?

We maximise our team resources on the project at busier times within the project plan to utilise all available time.

How do we overcome having only one Regulatory team member who doesn’t publish?

We have the experience to convert your authored Word documents to the required PDF format and publish them to submission-ready standards.  We work closely with our Regulatory Affairs colleagues to provide the best collaborative service.

How are potential risks managed?

We discuss common risks early in our relationship with clients, and our in-depth content plan is used between DLRC and clients to aid planning and communication.  It is a one-stop source of truth and allows all project team members to be updated.

What Technical Support is available?

We have our own dedicated in-house IT and System team managing and maintaining our eDMS and publishing platforms, this enables all parties to access immediate direct support without delay.

How can we address concerns about the difficulty of quality checking a large submission as a small company?

One solution could be implementing a more modular review process throughout the project, breaking up quality checks into manageable stages.

What happens when documents are not up to eCTD standards?

The validation software tool is used during our processes, and any issues will be communicated back to achieve early resolution.

Can you submit the application on our behalf?

Yes, we have accounts with all the major health authorities for streamlined uploads of applications.

What if we are working with a 3rd party for authoring, and they have different authoring styles and templates?

This is a widespread occurrence; documents received from any author will be reviewed, and if any eCTD standard requirements are missing, they will be added.

What if we don’t have access to document templates?

DLRC have a wide range of Word template documents with helpful hints and tips to guide you through the authoring process.

Do you have experience converting applications from one region to another?

DLRC has extensive experience converting applications for various regions. Our advanced publishing software reduces repeat effort, and conversions are straightforward.

How does DLRC work with global project teams?

We have experience working with global project teams in the past and present.  We have colleagues working across time zones to enable multiple-site delivery. We amalgamate working time zones to provide a longer working day as and when the project requires it.

End-to-end Delivery Across the Regulatory Operations Pathway

DLRC is available to provide as much guidance as required.  From a publishing standpoint, we can outline the essential and ad-hoc stages you may need to fulfil the obligations of an initial submission.  We have state-of-the-art tools and systems to manage documents, including the Veeva Vault system for document lifecycle and Docubridge eCTD build software. These systems will build a historical product lifecycle throughout the life of the drug.

No matter where you find yourself on your regulatory path, make DLRC your preferred partner for knowledgeable, efficient, professional, and friendly support. Don’t hesitate to contact the Regulatory Operations Team at DLRC by emailing hello@dlrcgroup.com or using the link below. Your success is our priority.

If you are attending any conferences this year, look out for the DLRC stand and chat with our representatives or make an appointment for a meeting.  They will happily answer your questions and provide more comprehensive details of how the Regulatory Operations team can work with your company.  A list of the events we are attending can be found here.