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Regulatory Affairs - Research & Advisory Services

Regulatory Affairs

The role of Regulatory Affairs groups has become more critical in recent years as regulatory bodies, such as the Food and Drug Administration (FDA), demand more visibility throughout the new product development process. Regulatory leaders' ability to smoothly guide new product development from early screening through clinical trials to New Drug Application (NDA) and to communicate effectively with review boards and investigators not only means higher chances of product approval but also immense time and cost savings.

Research and Advisory Services provides benchmarks and best practices for Regulatory Affairs professionals on developing sound submission documents and facilitating the commercial and scientific exchange on cross-functional development teams.

Let Research and Advisory Services analysts show you how the practices of leading companies can help improve your Regulatory Affairs function. Our expertise spans critical areas of Regulatory Affairs, including:
  • Best practices for Regulatory Affairs organziational structure, staffing and investment
  • Identifying requirements for clinical trials, pre-clinical through phase III
  • Preparing FDA submission documents for INDs and NDAs/BLAs
  • Effectively communicating with regulatory bodies and external parties
  • Building effective cross-functional development teams
Explore these and other topics with us during a Virtual Presentation of our resources, capabilities and solutions tailored to support your success.

Benefits of a Partnership with Research and Advisory Services

  • Decision Support Research to Benchmark Your Function and Learn from Best-in-Class Regulatory Affairs Groups
  • Access to Strategic Research Projects around Regulatory Affairs Excellence
  • Unlimited Access to the Best Practice Database for Quick Access to Key Regulatory Affairs Best Practices
  • Personal Interaction with Senior Analysts With Years of Experience in Benchmarking Regulatory Affairs Excellence
  • Exclusive Networking Forums for Professionals from Regulatory Affairs, Clinical and Commercial Groups
Contact us:

Christopher Bogan,
President and CEO

Phone: (919)-767-9228

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