4 considerations when choosing a solution for managing global regulatory submissions

by Dawn Waite and Sadia Ahmed

There are so many balls in the air when managing global regulatory submissions that it’s all too easy to lose sight of the bigger picture. That picture really should be focusing on the portfolio, building your regulatory intelligence and strengthening your position in the market.

But the day-to-day strain of handling submission requirement updates from different regions, arriving at different, unspecified times and requiring painstaking management can detract from the value-added capabilities that regulatory departments should be focusing on.

For this reason, many companies have chosen to get external help. But it shouldn’t be assumed that any help will do; in fact, cut-price support is all too often a false economy. So, what do you need to consider when it comes to managing your global publishing requirements?

Broadly speaking, there are four major criteria to consider: flexibility, depth of knowledge and expertise, global reach, and interoperability

Flexibility must extend to how well a solution integrates with the authorities. For example, the U.S. Food and Drug Administration’s WebTrader allows companies to communicate with the authority. But for greater speed and continuity, regulatory departments should be able to have a single point of contact to that gateway. If the vendor solution enables that contact through the cloud, it removes the logistical challenges of getting data from different places or dealing with connectivity issues.

Many larger companies have implemented dedicated cloud platforms, simplifying this process, but for smaller companies that’s not always feasible. Here, a multi-tenant solution makes sense, allowing them to make the most of that functionality at a lower price point. But that multi-tenant platform must be flexible, able to adapt to changing needs, and must be a secured and validated environment. Being able to access a prevalidated multi-tenant environment means companies can reduce the time and cost involved in installation and qualification of the software.

Depth of knowledge comes down to industry experience and capabilities. If a regulatory department is handling the publishing logistics internally, the team must keep up with all the operational tasks, such as managing all submission updates from affiliate offices and keeping track of each one. The team must also understand all the finer nuances of the solution.

Size and reach are a must for managing regulatory submissions in multiple countries. It’s not only that each region has its own publishing requirements — some use electronic Common Technical Documents (eCTDs), some paper, and some non-eCTD electronic submissions (NeeS) — but also that timelines vary from region to region. You want to know that your publishing vendor understands those regional variations and can quickly respond to requirement updates from different parts of the world and at any point in time.

Interoperability is another important consideration. Do your publishing solution and platform integrate with ancillary tools as well as other internal solutions, such as your content management solution and authoring tools? Regulatory departments need all those capabilities available from one location to reduce their workload.

The operational challenges that often bog down regulatory departments when dealing with global regulatory submissions can be simplified with the right support.

Learn more about DXC’s Publishing  capabilities.


Sadia Ahmed has more than 18 years of experience in IT and the life sciences Industry working in research and development and global management functions. She has extensive global knowledge of regulations and guidance for electronic submissions. She currently works as product manager for DXC’s Publishing Suite for regulatory publishing.

 

 

Dawn Waite is a digital transformation lead and is responsible for the Life Sciences Regulatory Managed Cloud for DXC Technology. She and her team work to drive transformation with the life sciences sector by engaging cloud technologies to facilitate greater use of data and enable organizations to remove siloed data and reap greater benefits.

 

 

 

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