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Regulatory Requirements Database

Whether new product introduction or change management, UpToDate requirements that are reliable is important. In addition, knowing draft (in flight) guidance will help formulate short and long term strategy will address and provide overall definition and clear direction for your product development team, even outlining the reasons for the path to be taken.

To accomplish this, we include these 4 areas

  • Global Regulatory Requirements Database (covers different business/functional areas including clinical, market launches, Vigilance, Testing standards, submission checklists, fees, labeling, import/export, marketing, safety/PV, renewals/variations and life cycle requirements)

  • Regulation & Guidance documents repository search

  • Regulatory document creation (you can use your templates), collaborative review (both with internal and external stakeholders, while users who do not need to have login access to this system), auto-format (system will do all document formatting from fonts to tables to headers/footers etc.)

  • Project creation (for long-term or large projects you can create tasks, assign to team, track – full online project module included)

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