November 23, 2021 Regulatory Automation

Leveraging Automation in Pharma Regulatory

Regulatory affairs is playing a pivotal role in bringing products to market swiftly, hence this is a sensible place to start in applying intelligent automation technologies for the operational excellence.Though the pace of technological changes are accelerating, pharma regulatory industry is going slow.It is an ever changing market, if fail in up to date in technology that will badly affect the growth of the industry.

Now it is a big challenge for the pharma regulatory teams to stay on top with frequent changing updates. It is not an easy task to monitor the entire regulatory landscape due to sheer amount of data is available, although the extensive availableinformation is considering as a positive sign.Here another point to understand is that, it’s becoming harder to discern the valuable intuitions from the noise. These regulatory updates and happening changes together combined with the speed and contributing an increaseof burden to the regulatory teams.

Thankfully, with the recent advancements in potential digital transformation including artificial intelligence (AI), machine learning across many of its activities like routine processes of pharma regulatory is harnessing the technology power to surface more insights than ever before. Other regulatory facets like Chemistry, Manufacturing, and Control (CMC) are evolving with automation, robotics, analytics, and block chain advancements. And they are becoming mainstream in strategic and operational functions.Below are some of the new developmental breakdowns in AI that are paving the way for pharma regulatory industry to increase efficiency now, and into the future.

Data Silos Handling

Regulatory teams are facing inconsistent and incomplete data filing issues across the world due to prevailing non-interoperable legacy enterprise systems. It is difficult to determine if the organization is using the documentation process, specifically when different users in the world are using distinct systems, which leads to unreliable filings and submission errors. This is where the power of technology advancement like automation and AI can be leveraged effectively,to hypothesize and create an intellectual web-based system with access to all artifacts. This kind of advanced application support for a ‘single source of truth’ which helps in providing complete and consistent reliable data through a central repository to all similar documents.Further more AI, automation increase productivity, improve customer service, help the regulatory teams meet compliance requirements, and finally lower the costs.

Regulatory CMC Data Automation

With the current traditional regulatory CMC systemic approach, analyzing, processing, assembling, archiving, ensuring cost effect, and efficient data exchange is really a tough job. This process makes regulatory submission delay that lead to delay in drug approvals, which further delay in marketing the product. If the important CMC data is not managed properly by pharma companies, they will have to face a vulnerable situation of non compliance. Furthermore data integrity issues arise which may be a possible situation of application rejection and degradation of the organization’s reputation. To overcome all this type of challenges, it is good for pharma companies to analyze the current drawbacks in regulatory workflow, find technical, operational gaps and adopt new tools like AI technologies.

Majority of the pharma companies are relying on manual processes especially in regulatory team, which is laborious manual system more often lead to delay and human errors. Specifically for regulatory affairs teams this kind of outdated technology is causing million dollars of incur every year. Updated technologies for regulatory teams help in improving the efficiency of current workflows, and in communication of regulatory changes and pharmacovigilance. Adopted AI technology will take off the burden to employees and freeing up their time to focus more on information analysis and assessing the impact on changes that will effect the organization’s reputation.

Available Solutions for Regulatory Problems

Luckily there are many advanced technologies available to regulatory departments enable them to monitor and gather critical insights, reduce the risk of missed information and help them stay compliant. More specifically, this technology helps to tackle regulatory issues faced by the teams, few are discussed below:

  • Simplifying Overloaded Information : In the current scenario,it’s really becoming increasingly difficult to keep up with critical information and insights, so leveraging the power of AI in helping to filter regulatory updates, it will ensure no ‘noise’ slips through the net when coupled with human expertise. This will help regulatory team’s confidence that the received updates are of highest qualitythat can maximize the ROI on information sources.
  • Real-time Monitoring of Data Landscapes : Withthe advanced technologies information related tomultiple regulatory bodies, news sources, and premium sources can be enriched and integrated to havereal time updated experience. If regulatory teams centralize this key information into single source they can save huge amount of money and time
  • Smart Operation : AI, machine learning, data science pushes data driven models through smart alerts to mobiles, weekly news briefings, workflows, API access for powerful services and workflows, etc.


The ultimate goal of regulatory teams is to meet the standards set by the regulatory bodies and keeps their organizationsbusiness momentum without impacting the desired outcome.So, investing in solutions that harness the power of technologies will help in reducing the cost by improving ROI. Automation in the regulatory industry ensures data reliability, can connect to more different data sources and can conduct data crosschecks.Regulatory process automation acts as catalyst for existing toolsin fast-tracking regulatory submissions, and accelerating product approval processes.

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