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International Regulatory Expertise

Regulatory proficiency and filing strategies in more than 70 markets













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The One 2 One Global Regulatory Affairs team is focused on the regulatory success of your product. The team provides comprehensive support for each parenteral product throughout the global registration processes. Included is expertise in:

  • Common Technical Document format (CTD)
  • e-submissions
  • global filings, strategies for the Americas, Europe, Asia Pacific and ROW
  • review, approval, and post-approval phases, including annual reports
  • handling inquires from the FDA, EMEA, MHRA, Health Canada and other regulatory agencies
  • supported more than 250 regulatory submissions and more than 25 DMFs over the last five years for One 2 One customers



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