Be Systems and Process Aware: Records, e-Signatures and Validation

Over the past couple of blogs – Be Prepared and Understand the eCTD challenge – I have talked about the challenges pharmaceutical companies with limited marketed product experience face, particularly when seeking to bring products to the larger markets. An important consideration is to understand the expectations and preference of the authorities. Regulators want to […]

Understand the eCTD challenge: The what and when of dossier submissions and changes

As I discussed in my last blog, solid document management is paramount for successful regulatory submissions in the larger markets. In the majority of major markets submissions must be done electronically through the electronic common technical document (eCTD). In principle, the eCTD is a simple structure to allow the dossier of all those documents created […]

Be Prepared: Document management for the uninitiated – Part 1

The push to conduct clinical trials and bring products to market in the EU often catches companies with limited marketed product experience off-guard. As they progress through the clinical development phases, they develop a large library of completed and approved documents which comprise their dossier. There is an assumption that this emerging monument to effort […]