Expanding Portfolios Cause Structure Shifts for Regulatory Affairs at Growing Pharma Companies

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--A new study by Cutting Edge Information finds that growing companies dealing with larger portfolios tend to decentralize their regulatory affairs groups in pursuit of geographic or therapeutic specialization. However, in the long run this results in a lack of uniformity and difficulty communicating across branches. Smaller companies favor a centralized structure at a ratio of 3:1, but expansion tends to drive decentralization.

“Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy”

The study, “Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy,” finds that large pharmaceutical companies are simply too big to have the same level of centralization as smaller drug companies. The analysis shows that the decentralization trend is reversed once companies’ portfolios grow large enough where the structure loses its efficiency and becomes a stumbling block. Drug companies then typically restructure to a “hub-and-spoke” organization. Companies develop standardized procedures through a central department that coordinates strategy throughout different affiliate teams.

“Communication is absolutely critical for regulatory affairs teams,” said Ryan McGuire, research team leader at Cutting Edge Information. “Companies with decentralized structures should put in place regular, two-way communication to make sure that the affiliates have a way of both learning what the global center expects of them as well as reporting local changes or challenges that will inform the global strategy going forward.”

The report recommends that growing companies establish a centralized regulatory affairs group with extensive experience in various markets. Ensuring that the team brings veteran regulatory affairs specialists to the table will avoid costly mistakes in the approval process that smaller, less experienced companies are prone to.

“Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy” (http://www.cuttingedgeinfo.com/research/regulatory/market-approval/) provides in-depth spending, staffing and timeline benchmarks, as well as case studies, to support and strengthen regulatory affairs teams. The report supports key goals identified by benchmark partners:

Boost team productivity by attracting and retaining top talent.
Stay competitive with year-over-year budget benchmarks and projections.
Manage the impact of globalization by implementing processes and best practices to quickly adapt to changing regulations.

For more information about regulatory affairs, pharmaceutical compliance and effective submission processes and strategies, contact Elio Evangelista at 919-403-6583.