You are here: Home Products  Submission Creation & Lifecycle Management 

Submission Creation & Lifecycle Management

In both the pharma and crop industries, a safe and compliant submission and lifecycle management software is essential for business success in a fast changing environment with constantly evolving requirements and regulations.

EXTEDO’s products – eCTDmanager (DOCmanager, RLPmanager) for the pharma (human and veterinary) and medical devices industries, as well as PlantOS 3 for the crop industry – give you the necessary support to build, view, validate and publish compliant submissions.

Customer Quote

"CanReg has been using eCTDmanager software from EXTEDO since year 2005. We use this software to prepare all our eCTD submissions with U.S.A. FDA, EU EMA, individual EU Member States, and Health Canada. Since 2005 we submitted well over 1000 successful eCTD submissions for all major application types, including INDs, NDA/ANDAs, DMF/PMFs, MAAs and NDS/ANDS. No eCTD submission filed by us, ever received RTF or any negative feedback from regulatory agencies."

Ted Hanebach, Director Regulatory Operations at OptumInsight (formerly CanReg)