For many small and mid-sized life sciences companies, eCTD submission publishing becomes a challenge as soon as products move closer to registration. What often starts as an internal “we can manage this ourselves” task quickly turns into a recurring bottleneck. Limited resources, evolving regulatory requirements, and increasing submission volumes make it difficult to maintain quality and timelines.
At this point, many organizations decide to outsource eCTD submission publishing to a specialist. Outsourcing can bring expertise, flexibility, and risk reduction - but only if you choose the right partner.
In SMEs, regulatory affairs teams are often small. In some organizations, the same specialists responsible for regulatory strategy, dossier authoring, and agency communication are also expected to handle eCTD compilation and technical validation.
Having a limited number of resources almost inevitably puts a strain on them. This can have significant consequences for the team in question, as well as for the organisation as a whole. :
High workload around submission deadlines
Dependence on one or two eCTD experts
Increased risk when those individuals are unavailable
eCTD publishing is not just a technical task; a huge part consists of constantly monitoring regulatory requirements and their updates. Depending on the range of your business and products, this can easily affect different countries, time zones, and agencies. For every submission, your experts need to be constantly aware of:
Regional eCTD specifications and guidance
Lifecycle management, granularity, and sequence structure
Agency expectations for different submission types
Keeping this knowledge up to date is demanding, particularly for teams that must also manage many other regulatory responsibilities.
Yes, the success of your submissions is not solely determined by the tools your team uses. However, it is much easier for your team to work efficiently and in compliance with regulations when they are using the right tool, which is always up to date. If you opt for an in-house solution, your organisation will need to ensure that your employees always have access to reliable, future-proof software. Guaranteeing this is an ongoing process that affects your internal IT department. Their tasks include:
Installing and validating software
Managing updates and new regulatory rules
Ensuring that validation engines and templates are current
Basically, a possible consequence of limited resources and capacity. Technical deficiencies in an eCTD submission, such as broken hyperlinks, incorrect lifecycle operations, or validation errors, are more likely to occur when the workload is too high and there is no opportunity for an internal check. This often results in:
Delayed evaluations
Additional questions from authorities
Rework and internal disruption
For SMEs, even small delays can have a significant impact on time-to-market and revenue.
Outsourcing eCTD publishing allows SMEs to:
Access specialized expertise - work with teams that handle eCTD submissions daily, across multiple regions and product types.
Increase flexibility and scalability - scale capacity up or down without recruiting and training additional staff.
Reduce internal workload - free internal regulatory teams to focus on content, strategy, and agency communication rather than technical publishing tasks.
Lower technology burden - use the vendor’s tools, validation processes, and infrastructure instead of managing your own.
However, outsourcing only creates value if the vendor is competent, reliable, and aligned with your way of working. Selecting the right partner is therefore critical.
When looking for a reliable regulatory publishing partner, you need to ensure the following points:
Experience with eCTD submissions to key authorities (e.g., EMA, US FDA, national agencies)
Knowledge of regional differences and current regulatory guidelines
A strong track record of first-time-right submissions
Reliable publishing is based on more than individual skills - there is a whole range of tasks and abilities you need to consider. When you ask a possible vendor for an outline of a possible project, this is what you should be looking for:
Documented publishing workflows and SOPs
Defined quality control steps and peer review of sequences
Use of recognized validation tools and clear handling of validation findings
Transparent management of lifecycle operations and submission histories
A professional vendor should be able to describe their process clearly - from receiving your documents to delivering a submission-ready eCTD sequence.
SMEs often have fluctuating submission volumes and need to be flexible when it comes to volumes. Your vendor should be able to support:
One-time or pilot projects (e.g., your first eCTD in a new region)
Ongoing publishing support for recurring submissions
Additional capacity for peaks, such as launches or large variation packages
Regulatory submissions contain confidential scientific and commercial data. Your vendor must protect your data all the time. That means they need to... :
Operate secure environments for data storage and processing
Follow strict access control procedures
Have appropriate backup and disaster recovery mechanisms
Even if you do not operate publishing tools yourself, your vendor’s technology matters. Unreliable systems that can not guarantee up-to-date information about current regulatory requirements will not support your compliance. Ensure the following points with a possible service vendor:
Use of established eCTD publishing and validation software
Regular updates in line with changing regulatory requirements
Ability to support additional formats or regions if your portfolio expands
If your company already uses regulatory software (for example, from EXTEDO), confirm whether the vendor can integrate smoothly with your existing systems and processes.
Finally, choose a partner that understands how smaller organizations work. Look for a vendor who knows what smaller and mid-size companies need, who can understand your needs, and where you are more than just another number. Make sure your vendor has experience with your organisational size and offers:
Awareness of limited internal resources and the need for efficient collaboration
Practical, right-sized solutions instead of overly complex processes
Willingness to provide guidance and advice, not only execution
You should feel that your vendor supports your long-term regulatory strategy, not just individual submissions.
EXTEDO combines regulatory software and services designed specifically for the life sciences industry. Our regulatory publishing services are built to address the challenges described above, especially for small and mid-sized companies.
Working with EXTEDO's Regulatory Document and Submission Publishing Services, you can:
Rely on experienced publishing specialists with daily hands-on experience in eCTD and regional requirements.
Choose flexible engagement models, ranging from support for a single eCTD project to continuous outsourcing of your publishing activities.
Benefit from the close integration between our services and our regulatory software solutions, ensuring that tools, validation, and processes are fully aligned.
Consider our team as an extension of your regulatory department, with clear communication guaranteed, as well as a focus on quality and compliance.
If your organization is facing capacity constraints, increasing submission complexity, or technology challenges, it may be the right time to evaluate a publishing partner. If you are not sure whether you prefer an in-house team or a supplier, and which model is the best one for your organization's regulatory submissions, have a look at our blog post for guidance: Comparing In-House vs. Outsourced Regulatory Document Publishing: What’s Right for Your Company? | EXTEDO
EXTEDO can help you assess your current situation and design an outsourcing model that reduces risk, improves efficiency, and supports your regulatory and business goals. Just contact us, and together we will find your way to regulatory excellence!