pharma regulation

In the last few years, global pharma companies have grappled with a trio of formidable challenges which have impeded their efforts to maintain compliance with constantly evolving regulatory guidelines. 

The difficulties of manual pharma compliance 

The first hurdle has been around the arduous task of manually researching and keeping up with the ever-changing regulatory guidelines. Ensuring compliance with intricate rules and regulations can be time-consuming and demand significant expertise and attention to detail. In recent times, this challenge has become even more pressing due to the rapid evolution of regulations across various jurisdictions. 

Pharma data silos 

The second challenge has been around departments operating in silos, which has hindered seamless collaboration and impeded the proactive adoption of regulatory guidelines. This fragmented approach has led to inefficiencies and increased risk of compliance violations. 

Inaccessible historical pharma records 

Lastly, the lack of access to comprehensive historical records has further complicated compliance efforts. Without a reliable reference point, pharma companies have struggled to identify patterns, learn from past experiences, and streamline their processes.  

This dearth of historical data has inhibited the development of robust compliance strategies which could potentially expose organisations to legal and financial repercussions. 

A Merit expert adds, “Fortunately, advancements in technology and data management have been reshaping the landscape, offering transformative solutions to these long-standing challenges. The integration of artificial intelligence, machine learning, and automated systems, for example, holds immense potential for the pharmaceutical industry, enabling companies to tackle compliance issues more effectively.” 

Role of Regulatory Intelligence in Pharma Compliance 

Regulatory intelligence is the process of gathering, analysing, and interpreting regulatory information and guidelines to ensure compliance with applicable laws and regulations. It involves staying up-to-date with evolving regulatory requirements, industry standards, and best practices.  

There are two sides to regulatory intelligence; market and operational intelligence. 

Pharma Market Intelligence now 

Market intelligence refers to the collection and analysis of regulatory information related to the broader market landscape.  

Data for market intelligence is usually derived from Government regulatory agencies and their official websites, industry publications and journals, market research reports, regulatory news portals and newsletters, conferences and seminars, industry collaborations, and the like.  

This information helps pharma companies make informed decisions regarding product development, market entry strategies, and overall business planning within the regulatory framework. 

Operational Pharma Intelligence Today 

Operational intelligence pertains to the internal processes, procedures, and systems within a pharmaceutical company.  It focuses on understanding how regulatory changes affect the company’s day-to-day activities, including manufacturing, quality control, supply chain management, labelling, and packaging.  

This intelligence assists in aligning internal processes with regulatory requirements, ensuring compliance throughout the product life cycle, and identifying any operational risks or gaps that need to be addressed to maintain compliance. 

In recent years, regulatory intelligence has witnessed significant evolution due to advancements in technology and data management. The emergence of AI-powered tools, automated systems, and digital platforms has enabled more efficient data collection, analysis, and dissemination of regulatory information, empowering pharmaceutical companies to proactively adapt to changing regulations and streamline compliance processes. 

Here are the many ways in which regulatory intelligence supports pharma companies in their compliance efforts; 

  • It systematically collects and monitors regulatory information from various sources, including government agencies, industry associations, and regulatory publications. This process ensures that pharma companies stay informed about new and updated regulations that may impact their operations. 
  • It works with regulatory intelligence professionals to analyse and interpret the gathered information to understand its implications for the company’s products, processes, and compliance obligations. 
  • It develops comprehensive compliance strategies tailored to the specific requirements of the pharmaceutical industry. It enables companies to identify gaps in their existing compliance practices and proactively implement measures to address them. 
  • It monitors regulatory developments, which enable pharma companies to identify potential compliance risks and proactively mitigate them. It helps in evaluating the impact of new regulations on existing processes, assessing the risk of non-compliance, and implementing appropriate controls and mitigation measures. 
  • Regulatory Intelligence teams regularly disseminates relevant updates and guidelines to key stakeholders within the organisation. The team provides training and educational resources to ensure that employees are aware of their compliance obligations and understand the impact of regulatory changes on their roles and responsibilities. 
  • It supports ongoing monitoring of compliance performance and facilitates internal audits to ensure adherence to regulatory requirements. It helps in identifying areas of non-compliance, implementing corrective actions, and maintaining a state of continual compliance. 

Working Towards a Tech-Oriented Connected Future 

In an era where there are insurmountable pockets of data, and there are ever-changing regulatory requirements, it’s safe to say that the need of the hour for global pharmas is to embrace a connected future where technology and regulatory intelligence intertwine seamlessly.  

A connected future can enable pharma companies to stay abreast of regulatory changes in real-time, proactively adapt to evolving guidelines, and streamline compliance processes.  

It can foster cross-departmental collaboration, breaking down silos and ensuring a cohesive approach towards compliance. And, technology-driven solutions can empower companies to harness historical records as valuable reference points, enhancing decision-making and regulatory adherence. 

This approach can lead to the development of a smart pharma enterprise that is compliant, and paves the way for a more resilient, innovative, and patient-centric future. 

Merit Data & Technology: A Trusted Web Scraping & Data Mining Partner, With a Deeply Ethical Approach 

At Merit Data & Technology, our team of data scientists have extensive, in-depth experience in working with data, leaving you to focus on the core areas of your business. 

Our data scientists understand your data needs and create customised tools to deliver the right data in the format you need. They scale up and scale down the data collection process based on specific needs and validate data quality before it is used for analytics and decision-making. 

To know more about our web scraping technologies and practices, visit 

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