Pharmaceutical Regulatory Affairs


Explore benchmarks and best practices designed to help pharmaceutical regulatory affairs teams elevate their strategic influence on product development. The study features in-depth discussions and data on improving crossfunctional coordination, educating internal teams on regulatory processes and improving communication with regulatory agencies. To facilitate these objectives, the study includes regulatory affairs structure diagrams and spending and staffing metrics.

Download a Sneak Peek Preview of "Pharmaceutical Regulatory Affairs" Here

See a full Table of Contents and sample material

Top Reasons to Buy This Pharmaceutical Regulatory Affairs Report

Build stronger relationships with regulatory agencies to ensure successful submissions: Encouraging open communication with regulatory agencies involves focusing on internal training and regularly communicating with government organizations early in the development process. Use this report to learn agencies’ unique communication preferences and requirements to effectively maintain relationships.  Furthermore, study how other companies develop core strategies and best practices to face challenges in different markets.

Establish a dedicated pharmaceutical regulatory affairs budget to enable greater flexibility: Due to the increasing costs of compliance and regulatory activities, many companies are dedicating larger regulatory affairs budgets year after year.  Examine budget breakdowns for both global- and country-level regulatory groups, including analysis on how those funds are allocated for technology, travel, overhead, outsourcing and other regulatory activities.

Increase cross-functional communication between regulatory, development and commercialization teams:  Some companies’ regulatory affairs teams struggle with other functions’ lack of regulatory knowledge.  The findings in this report will help regulatory managers increase communication between teams and better educate other groups of regulatory requirements.  Read about how other companies integrate regulatory strategy into trial design to yield satisfactory data for relevant agencies.

Key Questions that This Study Answers about Pharmaceutical Regulatory Affairs

  1. Which individual countries present difficult regulatory environments and what strategies do companies employ to overcome those challenges?
  2. What is the average pharmaceutical regulatory affairs budget and what are some internal sources of funding that other companies use to support their regulatory teams?
  3. What are other companies’ best practices for streamlining ever-increasing regulatory workloads?
  4. At which points throughout the product lifecycle should different internal groups work with the regulatory affairs team?
  5. Why is it important to involve regulatory throughout the product lifecycle?


Price $3,495
Publication Date January 2014
Pages 81
Chapters 3
Metrics 500 +
Charts / Graphics 50