Submission Stewardship Case Studies

Client Engagements:

• StartingPoint^®, Process Consulting, Submission Outsourcing, Submission Stewardship Program™
  The Regulatory Department of a small pharmaceutical company consisted of three people. Their company was very forward-thinking in their preparation for eCTD. As a first step, they purchased, installed and implemented StartingPoint^®. As the company grew, they deployed electronic document specialists to each of the contributing functional areas to facilitate the authoring process and to ensure creation of electronic submission-ready documents. More...
  
  
• StartingPoint^®, Process Consulting, Submission Stewardship Program™
  An emerging biotechnology company acquired a drug to enhance their product portfolio. The original IND for the product was previously submitted in eCTD format. Once the product was acquired, the client was responsible for continuing maintenance of the IND submission in eCTD format even though they did not have eCTD processes or tools in place. More...