SERVICES


Regulatory Affairs and Operations

Westat delivers leadership, guidance, and strategy you can count on for unwavering credibility and compliance throughout the entire project life cycle.

Westat’s regulatory affairs (RA) professionals build long-term client relationships throughout the development cycle of drugs, biologics, and medical devices. We interpret and relay regulatory requirements to help identify and mitigate risks and prepare and publish complex, compliant dossiers – all while helping sponsors meet key milestones throughout the evolution of the product development lifecycle.

A Trusted Liaison

Westat’s RA associates play a critical role in supporting client interests by liaising with the U.S. Food and Drug Administration (FDA) and other regulatory oversight authorities throughout the product lifecycle. Our team is highly skilled in managing multidisciplinary teams to develop complex dossiers including Investigational New Drug applications, New Drug applications, and Biologics License applications. The reliable RA team:

  • Ensures compliance with regulatory requirements and quality
  • Performs senior-level review of dossier documents, including meeting packages, responses to requests for information, protocols, informed consent forms, and investigational brochures
  • Provides client consultation in preparation for required audits

Detail-Focused Expertise

Westat’s RA professionals focus on the details of complex compliance documentation so our clients can focus on product- and trial-related activities. Our experienced Regulatory Operations team:

  • Prepares and publishes multi-document dossiers in compliance with electronic common technical document (eCTD) standards for submission to regulatory oversight authorities
  • Ensures that high-quality dossiers are submitted within established timelines through an in-depth understanding of eCTD technical requirements, proficiency using specialized software, and attention to detail
  • Maintains dossier documents throughout the product lifecycle and updates trial information as needed on ClinicalTrials.gov

With decades of experience, Westat’s RA team offer sponsors trusted, rigorous, and reliable expertise and execution to support their efforts in regulated product development.

View David Burgess profile

David Burgess

Senior Regulatory Affairs Associate

View Barbara Driver profile

Barbara Driver

Vice President and Clinical Operations Lead

View Melissa King profile

Melissa King

Vice President and Associate Director

View Julia Solarczyk Donnelly profile

Julia Solarczyk Donnelly

Regulatory Affairs Lead