Regulatory Intelligence in the Pharmaceutical Industry: The State of the Industry 2024

Regulatory intelligence is a broad term that varies from industry to industry. But, in most cases, it involves a three-step strategy:

• Monitoring information about changes to relevant laws and regulations;
• Analyzing data;
• Leveraging the data analysis to create a targeted action plan to ensure your company's compliance

All industries must maintain regulatory compliance. While the life sciences industry is no exception, pharmaecutical companies are particularly under pressure to monitor the changes taking place in the regulated landscape, and respond to them accordingly.

Increasing complexities surrounding variables like product developement, clinical trials and technological innovations make the pharmaceutical industry one of the most heavily regulated.

Fortunately, it is easier than ever to put robust regulatory intelligence strategies into place, thanks in part to the rise of useful regulatory monitoring tools, like Visualping.

Regulatory Intelligence in Pharmaceuticals

Regulatory Compliance and Beyond

The pharmaceutical industry is one of the most heavily scrutinized and regulated sectors worldwide, and it isn't difficult to imagine why; pharmaceuticals can have devastating health effects if not thoroughly researched and monitored for quality and safety.

Regulatory intelligence in the pharmaceutical industry requires Pharma and Biotech companies, as well as lawyers working as part of the organization's legal compliance team, to understand the regulations themselves, as well as the trends, players, the bureaucracies and regulatory forces that drive key developments in the industry. Once the regulatory landscape is mapped, practitioners can make strategic and informed decisions to minimize regulatory risks, and increase the business's success.

Although it takes work to understand and stay updated on the requirements of pharmaceutical compliance, the effort is well worth it. With a strong understanding of the regulatory landscape, companies empower themselves to avoid specific hazards, and develop proper plans and protocols to mitigate compliance risk.

Some of the risks of not monitoring regulatory changes and staying compliant with pharmaceutical regulations include large fines, lawsuits, damage to your brand and reputation, and business closure. Staying on top of the latest compliance requitements, then, is a massive undertaking, but with a big payoff.

Regulatory Intelligence Professionals in the Industry

Because regulatory compliance is so critical in the pharmaceutical industry, most companies have specialized departments or teams focused on both regulatory intelligence and compliance management, or on regulatory change management.

These teams are charged with learning about external compliance requirements, and staying up to date on all changes -- these days, usually with the help of regulatory change software. When critical changes occur, this team shares information, as needed, with the appropriate stakeholders in the organization.

These departments vary from company to company, but they usually include team members specialized in legal and regulatory compliance. Larger companies usually have dedicated teams with multiple full-time employees whose jobs revolve around compliance.

Smaller companies, on the other hand, have to balance regulatory intelligence with other job functions. For example, some companies assign responsibility for regulatory compliance to the operations manager, who must monitor the external regulatory landscape, and oversee compliance concerns along with their other duties.

Larger pharma companies have a leg up on smaller companies in this way since they have the resources and personnel to specialize in compliance intelligence. These companies are better poised to cultivate active regulatory intelligence vs. passive regulatory intelligence.

Roles and Responsibilities

What are some of the roles and responsibilities involved in regulatory intelligence? Some of the key duties of regulatory intelligence professionals in the pharmaceuticals sector include:

• Researching emerging compliance trends and patterns
• Analyzing regulations and interpreting them for the rest of the team
• Creating detailed reports on current, changing, and new regulations
• Consulting with the team or serving as an advisor in other areas of the company
• Developing strategies for company-wide regulatory compliance
• Developing and executing compliance training where needed

Regulatory intelligence analysts are responsible for gathering information about new or evolving regulatory activity.

For example, suppose new legislation that affects pharmaceutical compliance is passed. The analysts are responsible for disseminating that information and turning it into both helpful insights and actionable recommendations for the rest of the organization.

Active vs. Passive Regulatory Intelligence

There are two main approaches to regulatory intelligence: an active approach and a passive approach.

Passive Regulatory Intelligence

Passive regulatory intelligence involves:

• Monitoring
• Analyzing
• Disseminating

These three actions apply to regulatory information that is generally available to the public at large.

Passive regulatory intelligence is a less targeted approach that not only takes less time but also doesn’t require a great deal of specialized knowledge. This is because the information in question is not confidential but available to whoever wants to access it.

The passive approach may be practical for smaller companies or for employees who are wearing multiple compliance hats. It’s generally best suited for broader compliance trends as well as potential risks or new developments, such as changing legislation.

To summarize, these are some of the benefits of the passive approach to regulatory intelligence:

• Little to no specialized knowledge needed
• The ability to identify broad compliance trends

Some potential risks or cons of the passive approach include:

• Less targeted compared to the active approach
• Relies heavily on publicly available information
• Demands a continuous cycle of data collection, analysis, and information dissemination

The passive approach doesn’t work for every company, at least not on its own. In some cases, it may be better to use the active approach or a mix of the two approaches.

Active Regulatory Intelligence

The active approach involves:

• Collecting information, whether confidential, nonpublic, or public
• Leveraging niche industry knowledge
• Leveraging targeted connections and professional relationships

Although the active approach may involve collecting public information, it typically includes processes associated with discovering and collecting confidential information as well. Because the information is confidential, only someone with specialized knowledge or targeted connections in the industry can access it.

In order to successfully executive an active approach to regulatory intelligence, one must have:

• Solid contacts, usually with major players within the industry
• The ability to properly conduct strategic interviews
• Knowledge of how to handle confidential documents
• Knowledge of how to manage sources
• In some cases, surveillance skills

Organizations benefit from the active approach when they need specific information about a situation, target organization, or regulatory developments.

To summarize, some of the benefits of the active approach include:

• Gathering information specific to the needs of an organization
• Targeted, niche intelligence
• The ability to detect regulatory developments sooner than competitors

Some of the cons of the active approach are that this approach requires specialized skills and access to major players in the industry. In addition, the data collection process involves interviews, surveillance, and other strategies that make it more time-consuming and demanding.

Visualping

The Top Regulatory Intelligence Tool for the Pharmaceutical Industry

Laws and regulations regarding pharmaceuticals are very complex, and evolve at a rapid pace -- making compliance in the industry even more challenging.

Visualping is a regulatory change software that allows companies of all sizes and industries to track regulatory changes when they occur online. When there's an update on a selected web page you're monitoring, Visualping sends you and your team an alert, with a text snippet or screenshot of the change.

Alerts can be sent through email, or popular messaging apps, like Slack or Microsoft Teams.

Easy-to-Use

It offers powerful customization features, but you don’t need to be a tech whiz to use it. All you need to do is select the sites you need to monitor, decide how often you want the tool to check them, and provide an email address to receive alerts.

More Intelligence, Less Noise

With Visualping, you can track any web page you want on the internet for the legal and regulatory updates you're after -- like updates to state and federal bills and debate, regulatory agency announcements and news articles. You can monitor an entire web page for changes, or select parts of the page you care about.

You set the frequency at which Visualping will check the web page. Get real-time change alerts, or monitor a page every 3 hours, 6 hours, daily -- it's really up to you.

With the keyword alerts feature, you can filter through the noise and only get notified when a certain word or phrase you're interested in gets added to the page.

Quickly understand page changes

Regulatory updates are easy to understand with Visualping. Simply open your email alert to see what's changed with before-and-after text snippets and screenshots. In your user dashboard, you can go back and review changes, to analyze updates over time.

You can even generate historical change reports across monitored pages, to view many updates in a glance.

Amplify Regulatory Intelligence with Visualping

Regulatory intelligence is an important strategy every pharma or biotech company should use in order to stay compliant and ahead of their competition. Fortunately, Visualping makes staying up to date on compliance changes easier than ever. Get started with Visualping today.