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ISR’s New Report Provides Common Structures, Models for Pharma’s Regulatory Affairs Departments

By March 29, 2016December 20th, 2021No Comments

Informing the pharmaceutical drug development, manufacturing and commercialization industry.

Cary, NC – March 29, 2016 – Industry Standard Research (ISR) today announced a new addition to its Department Models and Structures suite of reports.  The new report aims to provide readers with a comprehensive assessment of the organizational environment and landscape of Regulatory Affairs departments at Top 50 pharmaceutical companies.  As the industry faces new challenges brought on by globalization and increasing or changing regulations, the Regulatory Affairs department plays an increasingly important role in gaining approval for new medications as well as ensuring access to needed medications.

This report was generated from 60-minute in-depth interviews with 13 experienced Regulatory Affairs professionals from 11 of the Top 50 pharmaceutical companies.  Interviewees, all located in North America and Europe, discussed their department’s structure, reporting lines, headcount, budget factors, current challenges and what they see changing (for the good and bad) in the future.

“Regulatory Affairs departments are under a lot of pressure to speed time-to-market while at the same time to gain approval for the most inclusive label possible for the new drug product,” said Kate Hammeke of Industry Standard Research.  “This challenge is amplified by globalization and the differences in regulations by market, and the influx of new types of drugs that do not have a regulatory precedent to use as a guide.  As such, biopharmaceutical companies will benefit from the insights and best practices utilized by peer organizations by benchmarking how their own Regulatory Affairs department compares to the industry and ensuring any differences in size, structure and reporting contribute to strategic benefits.”

In the report, ISR points out “best practices” respondents identified during the interviews; additionally, these best practices are summarized along with potential solutions to existing challenges faced by the Regulatory Affairs departments.  The report may be used to compare a company’s Regulatory Affairs department size, structure, resources and approach to those of other companies which may be used to improve or streamline the function.

For more information on ISR’s “Regulatory Affairs: Department Models and Structures” report, please visit ISR’s report page at

About Industry Standard Research

Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR’s off-the-shelf intelligence and custom research offerings, please visit the company’s website at, email or follow ISR on Twitter