Proxima CRO

Regulatory support
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Five awards available.

Proxima will provide an introductory call with the awarded company to determine a specific regulatory/quality deliverable determined by the company’s stage of development.

If a regulatory deliverable is selected, this deliverable may be one of the following:

  • a formal assessment of regulatory pathway,
  • a formal assessment of Breakthrough Device Designation or STeP Designation eligibility,
  • support with an FDA interaction (such as review of an informational meeting or pre-submission packet), or
  • FDA meeting coaching and guidance.

Alternatively, a company may choose to elect quality management services, upon which Proxima will provide one of the following:

  • a QMS Kickoff and Plan,
  • review of 3 company-selected SOPs, or
  • 5 hours of QMS consulting.

About Proxima CRO

Proxima CRO provides regulatory and clinical research expertise to life sciences companies of all sizes and stages. We are a superpowered CRO joining forces with superpowered clients. With headquarters in the Texas Medical Center (TMC), the largest medical center in the world, Proxima CRO guides hundreds of emerging medical device, pharmaceutical, biotechnology, and diagnostic companies in 17 countries across five continents to further advance the $130 billion market. For more, visit ProximaCRO.com.

Proxima CRO