eCTD Compilation and Submissions via Gateway
With extensive experience in eCTD business, Croit has been conducting seminars and providing consulting services even before the PMDA accepted eCTD submissions. As a leading eCTD service provider, we will utilize our expertise to provide you with comprehensive support to aid your eCTD submissions.
１. Added value
Our cost-effective services cover operations from electronic application data creation and medical writing through to eCTD compilation and submissions while not sacrificing on quality. Cut your costs by removing the need to implement a new operation system, link data to your existing system, and secure personnel for system maintenance. Our service fees depend on your requirements and the number of target documents.
２. Assisting Gateway submissions for eCTD
We can create Gateway submission processes and help solve problems quickly by assisting you directly in your office or remotely by setting up your network in our office.
３. Quality assurance
Our standard operating procedures (SOPs) are created and maintained based on extensive experience and best practices. We constantly strive to make our workflows based on our SOPs as well as improving our staff by learning from industry experts. We ensure quality control with standard check sheets which we are constantly refining and improving.
４. Global regulatory submission services
We support regulatory submissions to FDA, MHLW, EMA, and authorities of other countries in partnership with global regulatory submission experts and software vendors.