ICH Guidelines

Registering new products in different countries is a time-consuming and nerve-wracking process. While the information required is essentially the same for various registrations as many countries have adopted the Electronic Common Technical Document (eCTD) standard, the preparation, presentation, and the depth of information submitted vary greatly depending on regional requirements.

Registering new products in different countries is a time-consuming and nerve-wracking process. For medical device firms, the process is part of an intense period of obtaining a 510(k) clearance or a premarket approval (PMA) in the United States. While the information required is essentially the same for various registrations, the preparation, presentation, and the depth of information submitted vary greatly depending on the country.

MasterControl offers the most complete choice of integrated software solutions covering all core areas necessary to successfully maintain quality and compliance processes, as well as a variety of services based on industry best practices.

Regulatory professionals in medical device, pharmaceutical and other regulated companies navigate a complex global compliance landscape filled with hurdles. Outmoded paper-based processes that are not connected cause delays and inefficiencies. Worse, departmental silos make collaboration more difficult, thus magnifying any inefficiencies.

The FDA mandated the electronic Common Technical Document as the standard format for submissions to ease the burden of pharmaceutical companies and help speed up the submission process. This white paper shares 12 tips for a successful eCTD submission based on a presentation by an FDA official.