Regulatory

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.

Top 8 Obstacles in Pharma & Biologics Product Registration & Submission Management

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™ 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.

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.

LORENZ Life Sciences Group and MasterControl Technology Integration FAQ

Learn how technologies of MasterControl and LORENZ work together to enable success in the electronic submissions process by helping customers collect documentation and manage submissions.

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.

MasterControl Submissions Ready™

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.

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.