Additional Content

Regulatory professionals in medical device, pharmaceutical and other regulated companies navigate a complex global compliance landscape filled with hurdles.

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.

Patricia Santos-Serrao describes the functionality of MasterControl’s regulatory suite.

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.

MasterControl Regulatory Excellence can help you collect, manage and submit all the artifacts you need to register your medical device.

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.

For medical device firms, the process of registering new products in different countries is part of an intense period of obtaining a 510(k) clearance or a premarket approval (PMA) in the U.S.

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

Having an idea for a medical device or pharmaceutical is the easy part. Getting that product through to consumers is more difficult. Fortunately, a good QMS can see you through the process.

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.