Regulatory Submission Services
Corporate Mission Statement
eSubGlobal is in the business of providing regulatory publishing and consulting services to the worldwide drug and medical device industries. We strive to act in the best interests of our clients, by providing superior electronic regulatory submission services at reasonable cost. Utilizing the most advanced hardware and software platforms coupled with expert XML programming skills we deliver validated, error-free, electronic INDs, NDAs and BLAs.
Submissions and Publishing
The publishing service takes client-originated research documents and formats them to the Common Technical Document (CTD) standard so that they are suitable for submission to regulatory authorities worldwide. These documents can originate from any client product development source including Chemistry, Manufacturing and Controls (CMC), (Module 3), Pre-clinical study reports (Module 4), Clinical study results (Module 5), which are required for IND, NDA or BLA submissions. Our eCTD publishing service is entirely managed on-line and is streamlined, time-sensitive and cost effective, while being ever mindful of customer's submission schedules.
eSubGlobal consulting service is manned by a group of senior regulatory affairs consultants each of whom possess deep experience with FDA rules and regulations. We provide regulatory gap-analysis of submissions plus advice and counsel regarding specific submission sections such as, Chemistry Manufacturing and Controls (CMC)(Module 3), Pre-clinical (Module 4) and Clinical(Module 5). The CMC section is a critical capability for clients needing help in choosing and optimizing scale-up and production of their Active Pharmaceutical Ingredients (API). Our CMC consultants have experience and deep understanding of upstream, downstream and production processes for a variety of protein and biological drugs and small molecule and are available on an as needed basis.
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