How Ready Are You to Respond to Heightened and Converging Submission Demands?

The pressure on life sciences companies is unrelenting. Not only must they find ways to speed up development, but they also need to hasten and improve the submission process. Clearly, getting your drug or product through the approval process as quickly as possible is in your best interests, as well as those of your patients.

But tackling the regulatory process requires deep and ongoing knowledge of the requirements and how these are changing. Since 2005, more and more countries have been switching away from paper or the non-eCTD electronic submissions (NeeS) format to the electronic common technical document (eCTD) format. Companies need to be able to respond to these growing eCTD demands.

So, what are the options? To add countries to your eCTD solution so you can handle multiple submissions at the same time, you want a solution that supports all these different formatting standards — one that lets you reuse the data without having to do a lot of additional manual work. That data should come directly into your publishing system from your content management and registration and tracking systems. This means you need to be on top of your regulatory information management capabilities to ensure a consistent flow of data that can be used across your various solutions, whether these are on-premises or in the cloud. The emphasis is on speed of submission.

Greater harmonization around eCTD should, in theory, be to your benefit. However, not all health authorities are as open and clear as the U.S. Food and Drug Administration (FDA), Health Canada and the European Medicines Agency (EMA). Often the standards certain countries require for their eCTD submissions aren’t clearly communicated, with just snippets of information being shared.

Therefore, it’s important that companies work in a partnership with their eCTD vendor to ensure that the latest information is shared with both parties and that the information each party has about guidances and specifications is consistent. It’s also vital for your vendor to stay on top of developments through research, attending forums and conferences, and working with the authorities, and then to translate that knowledge to its solutions.

Prepare for Change

One question you need to ask yourself is: How adaptable to change is your vendor?

Such adaptability should include the ability to rearchitect solutions to meet new eCTD requirements, new countries adopting the eCTD, or new submission standards such as Regulated Product Submissions (RPS), also known as eCTD 4.0., and Identification of Medicinal Products (IDMP). You should also be secure in the knowledge that your vendor has a strong, enduring relationship with the authorities and works closely with regulators to keep you ahead of change.

Another important consideration is: Just how holistic is the support your vendor provides?

Consulting support will be critical as companies prepare to manage new demands from authorities across the globe, such as the Association of Southeast Asian Nations (ASEAN) and eCTDs in the rest of the world (ROW). Medical writing, submission publishing, expertise in areas such as biometrics and Clinical Data Interchange Standards Consortium (CDISC) are important considerations. Having a partner that can support the full package — from software, to providing cloud services, to consulting — will help you meet those faster submission timelines.

Learn more about DXC Technology’s suite of Business Process Services that spans the full life cycle of regulatory related needs.


Kim Graf is a Product Manager with DXC’s Life Sciences group.

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