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FEATURED ARTICLES

  • 3 Regulatory Guidelines For Navigating China’s Drug Delivery And Medical Device Markets
    3 Regulatory Guidelines For Navigating China’s Drug Delivery And Medical Device Markets

    Global spending on healthcare medicines is expected to reach $1.3 trillion by end of year 2018. While many of these medicines may be developed in the traditional dosage forms, companies are increasingly developing more and more drug delivery devices, in order to deliver patient convenience, more effective routes of administration through targeted therapies, and value to the global payors. As the world’s second largest medical device market, China offers a significant opportunity for drug delivery companies to expand their global footprint in Asia.

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WHITE PAPERS & CASE STUDIES

  • The First Step To Navigating Your Combination Product’s Regulatory Pathway:  PMOA
    The First Step To Navigating Your Combination Product’s Regulatory Pathway: PMOA

    The drug-device combination product market is growing at a rapid pace. By 2019 it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012. This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained.

  • Warehouse Mapping Of GxP Storage Facilities: Why It’s Not An Option
    Warehouse Mapping Of GxP Storage Facilities: Why It’s Not An Option

    When your warehouse stores temperature sensitive pharmaceuticals and life science products, a top of the line HVAC system with carefully placed thermostats is not enough to ensure product quality and consumer safety. Why? It is the nature of warehouse facilities, no matter the size, to experience temperature gradients.

  • 6 Guidelines To Follow When Developing Combination Products
    6 Guidelines To Follow When Developing Combination Products

    While the development of a combination product comes with significant patient benefits through technology and molecule innovation, that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities.

  • Improve Your Facility Monitoring System To Comply With Regulatory Requirements
    Improve Your Facility Monitoring System To Comply With Regulatory Requirements

    A facility monitoring system (FMS) is a process monitoring tool that collects data from sensors such as optical particle counters, differential pressure sensors, and temperature probes in realtime. Acronyms are independent monitoring system (IMS) or environmental monitoring system (EMS). Software presents that data as information; real-time alarms notify facility operators of alert limits to enable an immediate response to an unwanted event or excursion. Reports and trend graphs can be produced.

  • Clinical Trial Logistics In Africa: Ensuring Quality, Compliance And Control

    Today’s Africa has increasingly become a source of fascination for pharmaceutical researchers drawn to the study and control of both communicable diseases such as malaria, tuberculosis and HIV/AIDS as well as diseases of the developed world like cancer, diabetes, hypertension and chronic respiratory disease. By World Courier

  • Exceeding GMP Of Medical Devices At Each Step In The Production Continuum

    Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.

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