Pharmaceutical

  • Top 5 Pharmaceutical Manufacturing Trends in 2020

    Top 5 Pharmaceutical Manufacturing Trends in 2020

    The following five trends reveal how the pharmaceutical industry as a whole is taking on a new look and how manufacturers can position themselves to remain competitive in the rapidly-changing pharma

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  • China’s Changing Pharmaceutical Landscape

    China’s Changing Pharmaceutical Landscape

    While already overseeing the world’s second-largest pharmaceutical market, China’s State Administration for Market Supervision is working to bring international drugs into the Chinese market faster.

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  • Top 5 Trends in the Pharmaceutical Industry in 2019

    Top 5 Trends in the Pharmaceutical Industry in 2019

    This white paper thoroughly examines five trends that are increasingly influencing the way companies are positioning themselves in a competitive and lucrative pharmaceutical industry.

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  • Top 5 Clinical Trends in Pharma and Biologics in 2018

    Top 5 Clinical Trends in Pharma and Biologics in 2018

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  • Top 5 Trends in the Pharmaceutical Industry in 2018

    Top 5 Trends in the Pharmaceutical Industry in 2018

    This white paper takes an in-depth look at trends in the pharmaceutical industry that are anticipated to make a significant impact on the sector in 2018.

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  • 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.

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  • eTMF Management Essentials

    eTMF Management Essentials

    Every organization engaged in a clinical trial must manage and maintain all trial-related content, documents, and data in a manner that supports the claims to the safety and efficacy of a product.

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  • Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments

    Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments

    The U.S. Food and Drug Administration has released data on the most common observations it makes during inspections of pharmaceutical facilities. This white paper explores the top 10 deficiences.

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  • Five Pharma Trends that Will Have the Biggest Impact in 2017

    Five Pharma Trends that Will Have the Biggest Impact in 2017

    The five trends that will likely have the biggest impact on the pharmaceutical industry this year, including TMF inspection readiness and the increasing focus on supplier quality management.

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  • ICH Q10 - Pharmaceutical Quality Systems - 'An Opportunity for Us All'

    ICH Q10 - Pharmaceutical Quality Systems - 'An Opportunity for Us All'

    The ICH Q10 Guideline 'pharmaceutical quality systems' was signed off as a Step 4 document at the ICH meeting in Portland, Oregon, in June 2008.

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  • 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.

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  • Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments

    Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments

    This white paper discusses six areas senior management tend to overlook, from proper investment in CROs to personnel training, and what the implications are in terms of compliance.

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  • How Software Helps Pharma/Biotech Maximize Value of External Resources

    How Software Helps Pharma/Biotech Maximize Value of External Resources

    Identify strategic ways that software solutions and automation can support overall efforts to secure external resources, from funding of research studies to establishing licensing deals.

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  • The Pharmaceutical Industry's Transition to Electronic Processes

    The Pharmaceutical Industry's Transition to Electronic Processes

    Pharmaceutical companies stand to experience significant operational advantages by transitioning to automated, electronic processes instead of continuing to use manual paper-based or hybrid systems.

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  • How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market

    How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market

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  • MasterControl EBR™ Toolkit for Pharmaceutical Companies

    MasterControl EBR™ Toolkit for Pharmaceutical Companies

    MasterControl offers this collection of resources to help pharma manufacturers on their path to paperless.

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  • 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.

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  • 12 Free Resources to Boost Your Pharmaceutical FDA Readiness

    12 Free Resources to Boost Your Pharmaceutical FDA Readiness

    This FDA Readiness Toolkit is designed to help pharmaceutical companies simplify compliance with FDA standards and streamline quality processes.

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  • 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.

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  • New ICH Q10 Harmonization Guidance for the Pharmaceutical Industry

    New ICH Q10 Harmonization Guidance for the Pharmaceutical Industry

    ICH Q10 is a guideline that describes a model approach for a modern pharmaceutical quality system.

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