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Clinical Research Organization ...

image of clinical submission, CTD and filing plan services Dante Resources is a specialized clinical research organization providing Filing Plan, CTD and clinical submission services to the pharmaceutical industry including device, biologic, and all other areas of development since 1993. All of Dante's colleagues are cross-trained and multitasked. All have advanced degrees and 20+ years of experience. We provide services and support 24 hours, 7 days a week and respond to stat, urgent and emergent needs.

Filing Plan Management ...

image for drug application support solutions Dante provides solutions to streamline regulatory approval with the following areas of service and support: medical writing, quality control, data management, project management, documentation consistency measures, regulatory expertise, regulatory submission management, project and clinical submission management and design, safety signal identification, efficacy endpoint analysis, biostats, SAS programming, clinical operations, clinical and medical affairs, and much more.

  CTD ROI ...

image for ROI-driven clinical submission solutions Dante provides ROI-driven clinical submission solutions - and is focused on drug development plans and programs, regulatory submissions, and success with approvals and action letters. Clients don't view Dante Resources as a typical clinical research organization; with a perfect 16-year CTD clinical submission track record (zero RTFs - Refusal To File - on any Filing Plan managed) Dante is viewed by clients as a preferred partner first and a clinical research organization second.

Dante Proudly Supports Diversity ...

Dante Resources proudly supports a wide range of diversity initiatives throughout the global business community.
  • NJ Association of Women Business Owners (NJAWBO)
  • Womens Business Enterprise National Council (WBENC)
  • Women Presidents Organization (WPO)
  • Small Business Administration (SBA)
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