Leveraging FSP Solutions and Expertise to Keep Up With Regulatory Intelligence Systems Monitoring

Few challenges in the industry are as important as staying on top of regulatory requirements, but their inherent complexity and continued evolution make it a real challenge — one often best met by an FSP solution.

Regulatory oversight is foundational to the safe and effective development and commercialization of new drugs and medical devices. Accordingly, a developer’s ability to master the flow of regulatory change is a major part of its overall pharmacovigilance (PV) success. Effective PV regulatory intelligence (RI) helps ensure that PV is executed accurately and cost-effectively across the entire development lifecycle. But effective PV RI can also be incredibly complex and is often too large a burden for small/medium biopharma, biotech and medical device companies that lack sufficient internal resources.

Fortunately, these companies are discovering something their larger competitors already know: A functional service provider (FSP) partnership is often the optimal solution for ensuring comprehensive and cost-effective PV RI. FSP partnerships are designed to outsource some or all required functions — like PV RI — and are applied to one product or an entire portfolio. Because FSP solutions can be customized to meet each developer’s unique needs, no matter how large or small, the FSP model ensures high-quality PV regulatory intelligence for every biotech or biopharma company that needs it.

Effective monitoring of regulatory intelligence comes with big challenges

The challenges inherent to PV RI encompass more than just regulatory complexity — though complexity is a major factor, given regulations are continually created, updated or revised, at all levels (regional, national and global), often all at the same time.

There is considerable urgency for effective and far-reaching PV RI because the consequences of failure are significant. For example, a biotech developer creating a new antiviral drug could miss a change in one aspect of a regulatory requirement, only to discover at the end of the process that they must restart a clinical trial or resubmit portions of their data. Delays cost money and can impact brand reputation, particularly in severe cases where failure to meet compliance results in a production stoppage or product recall.

However, in the modern biotech and pharmaceutical industry, a PV RI team needs to do more than just monitor ever-changing regulations.

It must also expertly translate RI, analyze how that intelligence applies to a product and make timely and accurate recommendations or changes. Today’s best PV RI teams are also involved in the regulatory process itself, meaning they need to have considerable depth and breadth of expertise, often across multiple geographies.

Given the multinational nature of many biotech and pharmaceutical companies, conducting business in multiple countries with multiple vendors is not uncommon. With this added layer of geographic and linguistic complexity, proactive and effective planning and communication across all regions is required to prevent important details from falling through the cracks.

FSP solutions are a great fit for pharmacovigilance regulatory intelligence compliance

Ongoing RI monitoring takes a systems-wide approach supported by high levels of expertise across the PV RI team. For many companies, an FSP partnership is the best way to engage a strong team of experts to monitor those RI signals and interpret and act on RI intelligence. An ideal FSP solution will deliver all the necessary capabilities to effectively and expertly monitor and translate data, apply those learnings, and make recommendations or implement changes.

There are many nuances to ensuring that the RI gathered and monitored is as effective as possible (as discussed in our recent white paper on the topic). FSP experts at the PPD™ clinical research business of Thermo Fisher Scientific are experienced across the PV life cycle to truly and effectively “master the flow of regulatory change,” and many are native speakers who can navigate regulatory complexities for their geographic location.

Our teams collaborate across regulatory affairs and clinical operations and play a vital role in overall PV lifecycle maintenance. This integration enables cohesiveness across the widespread range of functions that PPD™ Functional Service Partnership (FSP) solutions deliver. With end-to-end expertise across all phases of the PV life cycle, our engagements help mitigate unexpected delays and other surprises. Knowing the ins and outs of the entire PV domain and linking intelligence across all aspects of a product life cycle is how we ensure our clients get to market on time, reducing costs and avoiding expensive delays along the way.

Leverage our powerful regulatory and pharmacovigilance intelligence platform, RegView

PPD FSP Pharmacovigilance solutions deliver a structured and methodical system for proactive collection, interpretation and analysis, and presentation of all types of regulatory intelligence. Our deep regulatory and PV domain expertise, combined with the right infrastructure and technical platforms, enable efficient storage, analysis and dissemination of PV regulations and guidance. We operate a proprietary intelligence platform, RegView, that facilitates use and sharing of clear, comprehensive RI across the drug and medical device development cycles in more than 100 countries. With RegView, we capture the full range of country-specific PV regulations and procedural guidance, from legislative considerations to industry-specific thought leadership.

This wide-reaching platform is also connected to our client-facing system for automating and centralizing the safety report submission process for clinical trials. By integrating such details along with data from our clinical trial management system (CTMS) and the RI database, we quickly deliver real-time safety report submission data and intelligence when and where it is needed.

Pharmacovigilance RI from a proven FSP leader

PPD FSP Pharmacovigilance solutions are backed by more than 25 years of regulatory and PV domain expertise and enabled by industry-leading infrastructure and technology platforms that store, analyze and disseminate information. Our expert solutions are currently used by more than 250 clients and nearly 100 products.

As you strive to stay abreast of regulatory intelligence, partner with our expert team that will monitor all the relevant RI signals and interpret and utilize the full range of RI data. Leverage our comprehensive, focused and bespoke PV RI services designed to keep your product development on track and within budget.