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®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.