MedXview can provide its highly skilled personnel for use on-site to complete your most challenging submission projects. Our consultants are leaders in their respective fields, possessing cutting-edge skills, creative problem-solving talents with complete thoroughness and efficiency in the completion of their projects. They are carefully selected professionals, determined to effectively fulfill your exact needs in the areas of data processing and presentation, regardless of your time constraints. Our software developers are experts in C++.NET, VB, JAVA, and SAS/ AF/STAT/GRAPH/SQL and more. Our Regulatory staff has worked on countless successful electronic submissions projects such as eIND’s, eBLA’s, eNDA’s, and eCTD’s. We can provide support in submission leaf file generation such as CRT datasets, data definition tables (define.pdf’s), and tables, listings, and graphs. We have outstanding statistical analysis experience and can bridge the gap that sometimes exists between the biostatistics group and regulatory affairs.