AgencyIQ
Politico's Regulatory Intelligence Division is Readers Choice for Company of The Year

For more than 17 years, POLITICO has been a cornerstone of government affairs, providing essential journalism to lawmakers, lobbyists, lawyers, and others navigating the complex landscapes of Capitol Hill, the White House, the Supreme Court, the most active state legislatures, and election outcomes. When the organization decided that it wanted to expand to meet the needs of regulatory affairs professionals, it identified a gap. It became clear that helping regulatory professionals navigate daily policy changes in Washington, across key states, and abroad would require a different approach—one that addressed regulation in deep, hyper-specific detail and responded directly to the needs of their organizations. That gap led to the creation of AgencyIQ.

As a division of POLITICO, AgencyIQ seeks to function as a strategic partner and extension of its subscribers’ teams, offering regulatory professionals with reliable access to analysis, real-time data, and non-partisan journalism.

“Our vision is to enable businesses to deeply understand, seamlessly track, and effectively engage with regulators to accelerate action and improve outcomes,” says Alexander Gaffney, MS, RAC, Executive Director of Regulatory Policy and Intelligence at AgencyIQ.

At the Forefront of Regulatory Intelligence

AgencyIQ offers a suite of services designed to ensure that subscribers—a list that includes most of the top 20 pharmaceutical and medical device companies worldwide—stay ahead of the curve in an ever- evolving regulatory landscape. Its approach can be categorized into three primary areas: standard regulatory intelligence, bespoke requests, and comprehensive landscape analyses.

The company enables subscribers to access an extensive array of regulatory intelligence curated by a dedicated team of experts. Equipped with a team of nine regulatory professionals, AgencyIQ’s life sciences business focuses on identifying and analyzing critical regulatory updates, such as new guidance documents, regulations, FDA meetings, white papers, lawsuits, and legislation. These analyses save subscribers valuable time by delivering expert interpretations and insights in digestible formats.

AgencyIQ ensures that subscribers have the information they need, when they need it, by proactively addressing the questions and concerns of its audience. When subscribers need more however, AgencyIQ can help. Subscribers often seek assistance with bespoke, time-sensitive activities, such as attending FDA meetings or third-party conferences. AgencyIQ experts can attend those meetings and provide detailed reports. The service is particularly valuable when multiple subscribers have overlapping niche interests, allowing AgencyIQ to efficiently serve a broader life sciences audience.

Meeting Subscribers’ Specific Needs and Timelines

Gaffney notes that subscribers frequently request updates on specific areas of interest, such as whether the FDA has issued any new guidance on real-world evidence. AgencyIQ’s team can quickly scan for relevant updates and provide comprehensive reports, ensuring that subscribers stay informed about critical developments.

Another vital service provided by AgencyIQ is the creation of detailed landscape analyses. These reports cover complex topics such as artificial intelligence, real-world evidence, and revisions to EU pharmaceutical legislation. Subscribers who need a deeper understanding of these areas can rely on AgencyIQ to deliver thorough and neutral research.

The team works closely with subscribers to define the scope and content of each analysis, ensuring that it meets their specific needs and timelines.

Subscribers access AgencyIQ’s insights through a sophisticated and intuitive platform that also functions as a workflow and database tool. The platform houses regulatory documents, data and all the analyses produced by the research team, serving as a comprehensive resource for regulatory teams who otherwise find themselves monitoring a deluge of different government sources, emails, and data vendors just to keep up. The business continually expands its information and intelligence offerings, with plans to include inspection documents and data from the FDA over the next few months.

An Indispensable Resource for Regulatory Affairs Professionals

By employing regulatory experts who are often former practitioners, AgencyIQ builds on the journalism produced by POLITICO’s world-class newsroom with analyses specifically written to help regulatory affairs professionals manage their day-to-day activities more effectively. Unlike other service providers in the space, AgencyIQ doesn’t simply summarize press releases; it delves into the implications and context of regulatory updates. This approach builds trust with subscribers by demonstrating a comprehensive understanding of the regulatory landscape.

AgencyIQ’s writing style also sets it apart. Subscribers appreciate that the firm provides extensive context and background, catering to professionals who might be unfamiliar with specific regulatory changes. This approach ensures that readers, whether new to a subject or seasoned professionals, receive a thorough understanding of the current regulatory environment, the reasons behind regulatory actions, and the potential impacts on their sectors.

AgencyIQ goes beyond reactive intelligence by offering proactive and real-time insights. Proactive intelligence involves predicting and preparing for future regulatory changes. Subscribers receive information and updates on upcoming FDA activities, important meetings, legislative requirements, and important dates. This foresight enables regulatory teams to anticipate and prepare for developments, reducing the need for lastminute “fire drills.”

Real-time intelligence is another critical component of the offering. AgencyIQ’s team continuously monitors a wide range of regulatory activities, from contract notices and hiring updates to legislative introductions and congressional investigations. This comprehensive tracking ensures that subscribers are always informed of the latest and most important developments, helping them stay ahead of the curve.

“The unique combination of expertise, proactive and real-time intelligence, and deep contextual analysis solidifies our role as an indispensable resource for regulatory affairs professionals,” says Gaffney.

Focusing on Regulatory Matters with Rigor and Dedication

A prime example of their research excellence is the thorough monitoring of the FDA’s Diversity Action Plan guidance over the past four years. Back in 2021, AgencyIQ noticed that FDA staffers were emphasizing the need for equitable distribution of patients in clinical trials, aiming to prevent approvals based on disproportionately homogeneous groups. Recognizing the potential for significant regulatory action, the firm began closely monitoring this area. Their foresight paid off when the FDA’s Oncology Center of Excellence published a draft guidance document on this issue.

AgencyIQ continued to track the progress of related legislation in Congress, documenting every step as it moved through debates and permutations until it was finally enacted in late 2022 as part of the Food and Drug Omnibus Reform Act.

The firm didn’t stop there; it kept a vigilant eye on the FDA’s subsequent legal obligations and reported on developments, including the reissuance of guidance, which provided companies with additional time to comply.

This exhaustive tracking and analysis have provided AgencyIQ’s subscribers with invaluable insights. While other firms may offer high-level summaries, AgencyIQ dives deep into every detail, from policy shifts to the nuanced steps that shape regulatory outcomes. The firm identifies key influencers within the FDA and other regulatory bodies, offering a comprehensive view of what these policies mean for various sectors, including rare diseases, pediatric oncology, and orphan medical devices.

“We are an intelligence agency, focusing on regulatory matters with the same rigor and dedication as national intelligence organizations,” says Gaffney. “Our work involves extensive research, data analysis, and human intelligence, aiming to uncover crucial information that influences policy and decision-making.”

During the early days of the COVID-19 pandemic, AgencyIQ demonstrated its value by swiftly addressing subscribers’ uncertainties regarding the FDA’s emergency use authorization (EUA) pathway. Drawing on prior expertise, the firm provided detailed explainers and kept close track of FDA actions. Its timely insights helped top medical product companies navigate the EUA process, contributing to the rapid market entry of critical therapeutics, vaccines, and diagnostics.

Setting its Sights Abroad

AgencyIQ’s international journey began with an expansion into European regulatory coverage. The move was driven by subscriber demand and a recognition of the need for clear and accessible regulatory insights on a global scale. The success of this expansion is a testament to the robustness of AgencyIQ’s methodology and its commitment to meeting the needs of regulatory professionals worldwide. “POLITICO’s reputation as one of the world’s most trusted sources for high-quality information on politics and policy, combined with its foothold in Brussels, puts AgencyIQ in a strong position to expand geographically, especially in Europe” says Joseph Kenol, AgencyIQ’s Vice President & General Manager.

In addition to geographical expansion, AgencyIQ has ventured into new industry verticals to address adjacent regulatory landscapes. One of the notable new verticals focuses on chemical regulations, particularly the activities of the Environmental Protection Agency (EPA), European Chemicals Agency (ECHA), and U.S. state agencies. AgencyIQ is also exploring other areas, such as food regulation, to broaden its scope and provide valuable insights across various regulatory domains.

AgencyIQ is not just expanding geographically and vertically but also enhancing its platform with innovative tools designed to save time and provide deeper insights. “Our goal is to develop a product that sits at the center of the regulatory toolkit and adds enough value to be viewed as a must-have for anyone who works in or adjacent to regulation,” says Kenol. Among those tools are novel document types and alerting capabilities that keep subscribers informed about the latest regulatory updates. A notable feature is one that allows subscribers to interact directly with research analysts via the platform, offering a personalized and responsive service that distinguishes AgencyIQ from traditional news offerings.

AgencyIQ continues to evaluate opportunities for future growth, constantly seeking ways to serve regulatory professionals across various industries. The company’s commitment to excellence, innovation, and engagement positions it as a leader in regulatory research, poised to make significant contributions to the field in the years to come.