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The Montrium Blog

The most helpful and thought-provoking ClinOps content from our writers on the front-lines of the life sciences industry

We've all experienced those late-night sessions running around trying to get those last pieces of regulatory content finalized for our upcoming drug application. We tell ourselves, this is the last time I am going to do this, however, ultimately, we know it isn’t.

Why do we often find ourselves in this situation?

Usually, it's due to a lack of planning behind the regulatory submission process, and complications caused by a large, dispersed team involved in producing all of the various pieces of regulatory content. Then we start working towards a new drug application and it seems this problem is multiplied 100-fold!

Getting submissions in on time is key to speeding up time to market, however, time pressure can also have a negative impact on quality, which ultimately leads to rejected submissions, increased costs and even longer timelines. By combining better regulatory submission process planning with the use of technology, we can begin to positively impact the results of our regulatory submissions. 

So, how can teams ensure their regulated content is submission-ready?

There are multiple factors that contribute to improved submission readiness to comply with life science regulations, and it is important to clearly define what these factors are and how you will manage them. Understanding and identifying where technology can help improve the implementation and control of these factors is also key and will dictate how you develop your plan.

Developing a concrete submission readiness plan which outlines these factors can be a useful tool in ensuring that everyone is on the same page and that you have properly thought out how technology could improve your submission readiness. Let's discuss some of the six main factors that improve regulatory submission process and submission readiness and how leveraging collaborative technology can help.

Document Management

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