DDReg Pharma- Consulting in regulatory affairs and drug safety

Pharma regulatory affairs is centered around the common technical document (CTD) that is required for the registration of pharmaceutical products in all markets. In more recent times the shift from the CTD to the electronic CTD (eCTD) is being adopted by regulatory agencies worldwide to overcome challenges associated with large amounts of paper-based data and to help facilitate more harmonized and efficient submissions. This is because it enhances review and submission processes, results in more accurate & precise submissions, mitigates duplicate submissions (due to better document organization), and implements a single, standard format that is accepted worldwide. Implementing the eCTD 4.0 What is the eCTD 4.0? The eCTD 4.0 is the most recent eCTD standard that address some of the key limitations. It’s main goals are to implement changes that accelerate and maximize the efficiency of regulatory submissions; enhance the communication channel between sponsors and regulatory agencies...

A regulatory strategy for a product aligns the regulatory activities involved with a business goal or strategy to help deliver market access to the product. It also helps highlight problem areas and challenges, and proposed regulatory solutions to tack le these challenges. For a medical device, the regulatory strategy will involve pre-clinical and clinical testing that provides information on the safety and efficacy of the device before submission to regulatory authorities. Developing the regulatory strategy It is important to incorporate regulatory intelligence and the most up-to-date information on medical device regulations when developing the regulatory strategy. It must be noted that regulatory strategies will differ for various medical devices including which markets they are intended to penetrate. A regulatory strategy for a medical device helps ensures it is maintaining compliance, facilitates rapid market access, manages and mitigates risks, saves on cost, and supports innova...