Additional Content
MasterControl Regulatory Excellence™ Solution Overview
Regulatory professionals in medical device, pharmaceutical and other regulated companies navigate a complex global compliance landscape filled with hurdles.
The New Digital Pathway for 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.
10:18MasterControl Regulatory Suite Preview
Patricia Santos-Serrao describes the functionality of MasterControl’s regulatory suite.
MasterControl Registrations™ Toolkit for Pharma & Biologics Companies
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.
4:29MasterControl Regulatory Excellence™ for Medical Devices
MasterControl Regulatory Excellence can help you collect, manage and submit all the artifacts you need to register your medical device.
Get Ready: Why Designing Quality Into Your Product is Key to 510(k) Success
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.
How to Address 10 Common Pains in Dossier Management & Product Registration
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.
FDA Experts Offer Top Tips to Optimize Your eCTD Submission
This white paper shares 12 tips for a successful eCTD submission based on a presentation by an FDA official.
MasterControl Registrations™ Toolkit for Medical Device Firms
Registering products with the FDA in the United States or other regulatory bodies overseas is a key challenge for medical device companies.
MasterControl Registrations™
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.
MasterControl Regulatory Suite™
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.
8 Obstacles in Pharma Product Registration & Submission Management
Drug development is a lengthy and costly process, doubly so for pharamceutical companies that rely on manual processes.
1:38Running the Regulatory Gauntlet from Conception to Commercialization
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.
Infographic: 10 Common Pains in Dossier Management & Product Registration
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.