Regulatory Submissions Trends Survey 2002

Ellen Semple

DOI:https://doi.org/10.5912/jcb44

Abstract:

This Regulatory Submissions Trends Survey, conducted by CDC Solutions in December 2002, takes the first steps to gauge how regulatory departments of US and European life sciences companies are using technology today and how they plan to harness technology in the future. The results specifically present a baseline measure on how pharmaceutical, biotechnology and medical device companies (a) view future increased demand for e-Submissions technology usage, (b) anticipate people, process and technology changes as related to the dynamic regulatory environment and (c) supplement current capabilities with outsourcing vendors. As with any baseline survey, many of the results are important and warrant continued tracking to begin to uncover the best practices in regulatory submissions software.

Keywords:regulatory submission ,submission outsourcing ,regulatory trends ,common technical document ,CTD ,electronic common technical document ,eCTD ,21 CFR Part 11 ,regulatory publishing ,en ,