• Pharmaceuticals: Articles / News

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  • Three Steps to Improved Compliance Management - Pharmaceutical Industry

    Dave Richardson, Senior Analyst, Cutting Edge Information

    It's no secret that pharmaceutical companies have great concerns about their overall compliance efforts. In fact, in several conversations that I've had with executives from marketing, sales, clinical, medical and other functions, it's rare to hear that compliance isn't a hot-button issue.

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  • Top Reason for FDA-483 Citations - Pharmaceuticals

    MasterControl

    If you're looking to improve a single area in your FDA compliance initiatives, look no further than your quality control unit (QCU). A report by an official of the Center for Drug Evaluation and Research (CDER) shows that QCU-related issues comprise the Number One reason why pharmaceutical companies receive FDA-483 citations.

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  • Quality Control - Top Reason For FDA-483 Citations Among Drug Companies

    MasterControl

    If you're looking to improve a single area in your FDA compliance initiatives, look no further than your quality control unit (QCU). A report by an official of the Center for Drug Evaluation and Research (CDER) shows that QCU-related issues comprise the Number One reason why pharmaceutical companies receive FDA-483 citations.

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  • FDA Crisis: An Attrition of Brain Power

    Marci Crane

    If people are an organization's greatest asset, the FDA's current "people status" is one of serious attrition.

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  • 7 Critical FDA Concepts for Pharmaceuticals Quality Systems

    MasterControl

    From the discovery of penicillin in the late 1920s to the breakthrough anti-cholesterol and anti-HIV drugs being manufactured today, the pharmaceutical industry has always been in the front line of developing new technologies. But the industry has yet to fully embrace modern quality systems operations.

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  • How Will Personalised Medicine Have an Impact on Clinical Trials?

    Abel Ureta-Vidal, Managing Director, Eagle Genomics Ltd.

    How can genomics have an impact on the management of your clinical trials? With the growing understanding of genetic code within personalised medicine, could this signal a change in the size and scope of clinical trials? What does this mean for the pharma industry and the patient?

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  • Investigator Final Reports: A Tool for FDA Inspection Readiness

    Carl Anderson, Regulatory Affairs and Quality Assurance Consultant

    During the time I was an FDA field investigator I encountered many clinical investigators who were totally unprepared for the FDA inspection. I would receive a "deer gazing into the headlights" response from the PI who obviously didn't remember a thing about the audited study. There is an old saying, "you only get one chance to make a good first impression." Often they would turn to their study coordinator and ask for the answer, joking to me, "They do all the work anyway."

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  • From the Project Manager's Toolbox: Strategies for eCTD Marketing Application Submissions

    Rachel Cooper, Project Manager, Cato Research Ltd.

    Nothing may invoke fear in the heart of new, or even seasoned, regulatory project managers more than the preparation and submission of a marketing application in eCTD format for their company. At first glance, marketing application submissions can appear to be a tedious effort to manage with hundreds of documents and players, and requires orchestrating intricately detailed timelines and intertwined steps. A successful filing is possible but requires beginning with the end in mind by planning f

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  • Speeding Time To Market For Pharmaceutical & Biotechnology Companies

    Antoinette Azevedo, President & CEO, e-SubmissionSolutions.com

    Pharmaceutical, biotechnology and medical device companies that market blockbuster products can earn over $1 billion dollars per year once their products are approved for sale by the United States Food and Drug Administration (FDA). Approval by the FDA can result in rapid approval to market products on a global level. Companies can invest $1 billion dollars or more over the course of the discovery, research, and development phases of their product candidates. Patent protection can be extended

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  • Document Control Management Software From MasterControl Facilitates Quality Objectives

    MasterControl

    Speed-to-market objectives have long driven project management milestones in pharmaceutical/biotech companies. Today, with patent life seemingly shorter, a robust competitive environment, and stricter regulatory reviews, the concept of speed-to-market is being redefined. It’s no longer just about getting new medical technologies to the waiting healthcare community faster.  It’s also about accuracy in terms of how products are defined to regulatory agencies.Challenges that

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  • Top Benefits of Electronic GLP Management: What Non-Clinical Research Laboratories Should be the First to Know

    Diane Clements

    Industrialized nations, such as the United States, the European Union and Japan, have increasingly aging populations and are experiencing unprecedented growth in demands for healthcare and related technologies.

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  • Quality Management News

    MasterControl

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  • Product Development and Clinical Data Quality Management

    MasterControl

    The product research, development and approval road is long, arduous, and costly, especially for pharmaceutical companies that are still reliant on manual processes and paper-based systems.  According to an ongoing study at Tufts (hyperlink -- http://csdd.tufts.edu/About/History.asp), the average cost of bringing a drug to market jumped from $231 million in 1991, to $802 million in 2001, to the current estimate of more than $1 billion.  After a product is successfully launched,

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  • Things Change - Plan On It

    Denise Robitaille, RABQSA-certified lead assessor, ASQ-certified Quality Auditor and Fellow of the American Society for Quality

    This article was originally published by Quality Digest Magazine.

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  • Six New FDA Enforcement Policies: How They Impact You

    Dr. Marla A. Phillips, Director, Med-XU, Xavier University

    On August 6, 2009, FDA Commissioner Dr. Margaret Hamburg publicly announced the FDA's new enforcement strategy. This strategy involves six new policies that went into effect on September 15, 2009. What are the policies and what do they mean to you?

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  • Tools to Circumvent Pitfalls on the Path to Your IND/NDA Milestones

    MasterControl

    PharmaDirections presents a new webinar: Tools to Circumvent Pitfalls on the Path to your IND/NDA Milestones: Avoid risks, surprises and wasted resources with confident pre-clinical and CMC critical path planning.

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  • GxP Lifeline - Medical Device Newsletter

    MasterControl

    The GxP Lifeline Medical Device consists of general feature stories, additional articles, a list of conferences, trade shows, and other events for life science professionals as well as a monthly Did You Know piece. For each article, we also include links to related articles and websites.

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  • eMDR and Event Problem Code Changes: Are We There Yet?

    MasterControl

    Normally, "are we there yet?" is the annoying question kids, and some adults, ask during a drive to a summer vacation spot. As summer comes to an end, "are we there yet?" is also a good question for your company to consider with regard to two initiatives currently underway at FDA: eMDR and Event Problem Code changes.

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