Regulatory
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MasterControl Regulatory Excellence™ Solution Overview
Regulatory professionals in medical device, pharmaceutical and other regulated companies navigate a complex global compliance landscape filled with hurdles.
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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.
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MasterControl Regulatory Suite Preview
Patricia Santos-Serrao describes the functionality of MasterControl’s regulatory suite.
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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.
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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.
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MasterControl 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Running 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.
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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.
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