HOME | PRESS RELEASES | HOW TO ORDER | EVALUATE | CONTACT US | CAREERS | Japanese

Solutions for Regulatory Affairs

As a professional in regulatory affairs you author submissions and other regulatory documents to obtain approval to bring new or modified products to market, insuring that all applicable laws and regulation are observed. You establish and maintain regulatory compliance using information technology, SOPs, and manual processes.

Pharsight® supports your goals for regulatory management:

  • Maintain your study data and model results in a regulatory-compliant repository linked dynamically to your analysis tools including SAS, NONMEM®, WinNonlin, and S-PLUS.
  • Improve workflow by automating common and repetitive analyses and reporting for fast, uniform, validated output.

Pharsight is the established technology leader for regulatory compliant data management, reporting and analysis, strategic consulting services, and model-based drug attribute visualization software.

Products and Benefits for Regulatory Affairs

Data Management and Reporting

Pharsight® Knowledgebase Server™ (PKS™) — Enterprise data management system for secure storage and change tracking for PK/PD data and analyses.
PKS Reporter™ — Automated system for report authoring, updating, and review/approval.
WinNonlin® AutoPilot™— Software application for WinNonlin that automates creation of clinical PK analysis outputs for standard reports.

Benefits

  • Ensure regulatory-compliant data management for critical early drug development data and analysis results from Phase I, ADME, Toxicity, Drug Metabolism, PK and PK/PD studies.
  • Automate reference checking and ensure that all reports and analyses are carried out with the most recent data.
  • Increase productivity of reporting and collaboration in a regulatory-compliant workflow.
  • Automate standard analyses to improve consistency of messaging and interpretation and reduce error in output.
  • Streamline data management, analysis, reporting, QA and validation.
  • Support compliance with internal SOPs and standards as well as regulatory requirements.

Analysis

IVIVC Toolkit™ for WinNonlin—Enables the use of WinNonlin for in-vitro / in-vivo correlations.

Benefits

  • Leverage WinNonlin for powerful IVIVC exploration, development and team collaboration.

Strategic Consulting Services

A global team of scientific experts with a focus on using quantitative models to improve drug development strategy and decision-making.

Benefits

  • Optimize clinical development programs to maximize therapeutic potential, R&D productivity and commercial value.

Visualization

Drug Model Explorer® (DMX®) — Visualization and communication tool to explore and compare model-based product profiles.

Benefits

  • Assess modeled drug attributes and uncertainty versus competing therapies.
  • Visualize and communicate “knowns” and “unknowns” within and across development teams.

 

"SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. ®indicates USA registration."