Pharmaceutical

  • Top 5 Pharmaceutical Trends in 2020

    Top 5 Pharmaceutical Trends in 2020

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  • Supply Chain Benchmarking Data Reveals Differences Between Pharmaceutical and Medical Device Manufacturers

    Supply Chain Benchmarking Data Reveals Differences Between Pharmaceutical and Medical Device Manufacturers

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  • Top 5 Pharmaceutical Trends in 2020

    Top 5 Pharmaceutical Trends in 2020

    Pharmaceutical companies are striving to play a larger role as solution providers in the health care value chain. Already, organizations are devoting more effort toward identifying new markets...

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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

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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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  • 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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  • Risk Management for Pharmaceutical Companies Under FDA's Q9 Guidance

    Risk Management for Pharmaceutical Companies Under FDA's Q9 Guidance

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