Regulatory

  • MasterControl Regulatory Excellence™ Solution Overview

    MasterControl Regulatory Excellence™ Solution Overview

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

    More
  • The New Digital Pathway for 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.

    More
  • MasterControl Regulatory Suite Preview10:18

    MasterControl Regulatory Suite Preview

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

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

    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.

    More
  • MasterControl Registrations™ Toolkit for Pharma & Biologics Companies

    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.

    More
  • MasterControl Regulatory Excellence™ for Medical Devices4:29

    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.

    More
  • Get Ready: Why Designing Quality Into Your Product is Key to 510(k) Success

    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.

    More
  • How to Address 10 Common Pains in Dossier Management & Product Registration

    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.

    More
  • FDA Experts Offer Top Tips to Optimize Your eCTD Submission

    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.

    More
  • MasterControl Registrations™ Toolkit for Medical Device Firms

    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.

    More
  • LORENZ Life Sciences Group and MasterControl Technology Integration FAQ

    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.

    More
  • MasterControl Registrations™

    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.

    More
  • MasterControl Regulatory Suite™

    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.

    More
  • MasterControl Submissions Ready™

    MasterControl Submissions Ready™

    More
  • 8 Obstacles  in Pharma Product Registration & Submission Management

    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.

    More
  • Running the Regulatory Gauntlet from Conception to Commercialization1:38

    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.

    More
  • Infographic: 10 Common Pains  in Dossier Management & Product Registration

    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.

    More
  • loading
    Loading More...