Regulatory

Life sciences companies can take advantage of the growing global demand for new health care, products, devices and data if a good infrastructure of digital regulatory systems are in place.

Automation can help pharmaceutical and biologics companies along the path to a global product launch. This white paper identifies common problems with submissions and how best to address them.

MasterControl Registrations for eCTD is a cloud-based solution designed to streamline content generation and the collection and management of artifacts required for regulatory submission.

This white paper explains the processes and tasks necessary for regulatory compliance and how digital QMS technology is a driver for meeting requirements faster and getting products to market sooner.

Whether you're applying for premarket approval in the U.S., a CE mark in Europe, or a Shonin in Japan, the challenges are worse for companies using a paper-based or hybrid system.

This white paper shares 12 tips for a successful eCTD submission based on a presentation by an FDA official.

Registering products with the FDA in the United States or other regulatory bodies overseas is a key challenge for medical device companies.

The management of your regulatory dossier begins long before submisson. Control the creation, revision, approval, and amendment of documents in your dossier throughout the entire process.

Drug development is a lengthy and costly process, doubly so for pharamceutical companies that rely on manual processes.

Whether you're applying for premarket approval in the U.S., a CE mark in Europe, or a Shonin in Japan, the challenges are worse for companies using a paper-based or hybrid system.