Regulatory affairs groups play a pivotal and ever-expanding strategic role in the success of compounds, brands, and whole companies. Regulatory teams enable organizations to navigate an increasingly complex, global healthcare landscape amid the growing array of regulatory bodies, different and constantly updated guidances, and often struggling product pipelines.
As the responsibilities of regulatory affairs groups evolve, and these teams move closer to the C-suite, companies dedicate greater investment to their budgets. Despite this resource support, teams face ongoing challenges to balance heavier workloads as the margin for submission errors narrows — making the need for efficiency paramount. Top-performing companies reevaluate and develop innovative approaches to personnel, strategy-setting and processes to gain maximum efficiency.
This report provides in-depth spending, staffing and timeline benchmarks to optimize regulatory affairs performance. Complementing the data are leading executives’ strategic recommendations and best practices for overcoming the toughest challenges in the current regulatory environment.
Boost Team Productivity
Regulatory affairs groups have never been more vital to company health. Use the report’s year-over-year budget benchmarks and projections to stay competitive as you learn how to attract and retain top talent. Understand outsourcing decisions and the most sought-after skills in regulatory professionals.
Improve Submission Timelines
Even as regulatory affairs becomes more dynamic, success boils down to data submission and marketing approval. Compare timeline metrics across company sizes, and learn to identify and overcome hurdles in your regulatory processes to get products to market as soon as possible.
Manage the Impact of Globalization
Harmonization of regulatory policies is happening, but slowly. Implement processes and best practices to stay on top of changing rules and regulations.
The following excerpt is a key finding from the full report's executive summary:
Manage Expectations for Submission Timelines by Adjusting for Company Size and Regulatory Affairs Experience
Regulatory submission timelines are either longer or shorter than they used to be, depending on who answers the question. Objectively speaking, the FDA in particular has ushered in new accelerated timelines and shorter submission evaluation windows, meaning that companies should be experiencing expedited review times in the US. Figure E.3 [Figure included in full report] shows large and mid-sized companies’ evaluations of submission timelines compared to small and device companies.
Interviewed executives from large and small companies painted vastly differing pictures of the regulatory environment. Large companies with large headcounts, experienced personnel and long-standing relationships with regulatory agencies are in position to leverage that relationship toward expedited review times. This is in direct contrast with smaller companies, whose regulatory affairs staffs are significantly smaller and less tenured. Often these companies are comparatively new to the regulatory playing field, have not built relationships with regulatory agency personnel, and thus do not have a direct, familiar point of contact when trouble arises.
Moreover, experience matters. A consolidation of regulatory affairs experience within large companies is ongoing, and consequently submissions are streamlining there. Regulatory agencies are not likely to negotiate with regulatory affairs employees over submission issues: either the submission is complete or it is not. Avoiding such mistakes in the first place — something an experienced FTE is more likely to do — saves critical time and resources on behalf of the submitting company.
The most important factor contributing to coordination with a regulatory agency is the experience of the regulatory affairs team. A number of surveyed companies point out that experience is becoming a necessity within regulatory affairs groups. Nowhere is the benefit of experience more evident than when dealing directly with regulatory agencies.
While a number of smaller companies’ contact with FDA is limited to written correspondence, most large companies with vast experience on their teams report more direct communication with the FDA.