919.886.4587

WHO ARE WE?

Triangle Regulatory Publishing (TRP) specializes in Regulatory Operations and Electronic Submissions, helping clients successfully navigate all aspects of the regulatory environment. 

 

Our organization is comprised of a network of industry experts who specialize in ensuring marketing applications are successfully submitted and accepted.  Our team knows how to successfully navigate the ever-changing publishing standards and requirements of the Regulatory Authorities, gracefully managing every detail and deadline using leading industry publishing systems and tools.  

 

TRP is here to make the management of change painless.  We help clients navigate the new requirements and serve as a bridge between the old and the new requirements -- educating and supporting our clients every step of the way. We take pride in the meaningful relationships we have with our clients in which we are committed and dedicated to.

WHAT WE OFFER

Offerings include a wide array of options—from on site training's of client employees to complete submission of client projects. Clients are able to choose the level of support they require from our "menu of services" to best accomplish their goals in the most cost-effective manner.

  • Electronic Publishing and Submission of Marketing Applications, Amendments and Supplements

    • Project Management; Consulting

    • Application conversion from paper to eCTD – Ensuring eCTD Readiness

    • Pilot/Sample submissions

    • Establishing metadata, appropriate granularity and naming conventions

  • Clinical Study Report Publishing

  • Management and Submission of IND Safety & Adverse Event Reports

  • Document Formatting and Publishing

    • Word Style Guides​

    • PDF Navigation

  • On Site Training​