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Ensuring Your Success

 

Powell Regulatory Services strives to help clients of all sizes define and achieve their goals with respect to implementing efficient and effective Regulatory Affairs and Regulatory Operations teams.

ABOUT US

Powell Regulatory Services is staffed by experts with over 30 years of experience working with Life Sciences companies to improve the way they approach their regulatory submissions preparation and regulatory information management.

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OUR VISION

Powell Regulatory Services goal is to help clients achieve their potential by providing insights into industry "best" practices, regulatory standards, health authority expectations, and their corporate culture; then redefining their ways of working to ensure success

​SERVICES

  • Process Improvement & Optimization

  • Regulatory Information Management

  • Standards Definition

  • Regulatory Data Governance

  • ​Industry Benchmarking

  • ​User Requirements

  • ​Vendor Selection Assistance

  • ​Education and Training

    • ​Electronic Submissions (eCTD, RPS, etc.)

    • ​Submission Authoring

    • Regulatory Data Governance

  • CTD/eCTD Authoring Templates and Style Guide

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