GLP,GCP,信頼性基準下の生体内濃度測定ための分析法開発,ICH-M10に準拠したバリデーション,実測定業務,測定業務に付随する報告書の作成,当局への申請書作成,外部委託試験モニター
Development of analytical methods for measuring in vivo concentrations under GLP, GCP, and reliability standards.
Validation in accordance with ICH-M10 for in vivo concentration measurement.
Conducting actual measurements and generating associated reports.
Preparation of application documents for regulatory authorities.
Monitoring of outsourced testing.