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Services

Services

We recognize that not all clients require software or license. Some may have one-time needs while others have very custom requirements, such as collecting specific data points unique to new/existing products, or conducting impact assessments, or pool all “in-flight” guidance summaries to see near future, or more general routine creation of weekly/monthly custom newsletters

We support these diverse needs utilizing our expert team of Analysts and SMEs with backgrounds in Regulatory, Scientific, Quality, and Product/Tech backgrounds.

We also leverage our very deep existing databases like:

  • Access to regulatory requirements of over 170 countries covering Human Drugs, Medical Devices, Consumer Health (cosmetics, Dietary, Food) and others

  • 2 million regulatory and guidance documents repository

  • Approved products database

  • Global clinical studies database

  • Access local expert insights through expert summaries

Budget or cost models can be on a pay-per-use basis, or monthly fixed hours avoiding the burden of fixed full-time costs.

Business-model

Some Areas include:

  1. Regulatory Monitoring:Our team of global and local experts continuously monitor regulatory information related to several industries and other areas from Health authorities/agencies, notified bodies/ Organizations (ISO, ANSI, TUV, BSI…) and associations.
  2. Interpretation and Analysis:Our team will analyse information and our experts will provide a simple summary and a detailed instructions set to cater different regulatory areas. Organization can leverage the summaries and instructions set to FastTrack and optimize Regulatory projects.Our team of Local experts interpret the changes/ guidelines for regulatory teams who are Non native English speakers for ease of understanding.
  3. Compliance Guidance:Experts provide comprehensive guidance on achieving and maintaining compliance with regulations in the medical device, pharmaceutical, and consumer health industries. Our Team will assist in providing guidelines and instructions for filling documents, we also offer updates, Regulatory pathways for Quality Management Systems, Risk Management, and Post- Market Surveillance for medical devices.

Ask Vistaar

Ask ViSTAAR feature allows regulatory teams to raise queries online and our team will provide solutions, options and related documents.

  1. Ask ViSTAAR feature provides Client user with an option to send queries.
  2. Whenever user sends a query, ViSTAAR expert receives an alert and responds to that query and also can attach supporting documents
  3. On the other end, client receives an alert when ViSTAAR expert sends response with a usual turn-around in 1-3 days

For any of your custom reports or projects, please reach us for customized pricing.