Structured Product Labeling (SPL) and Structure Product Monograph (SPM) are the mandatory document mark-up standards for the submission of label content, product and facility information and any subsequent changes to the existing label information in an electronic format.
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November 18, 2020 Regulatory Affairs, Publishing & Submissions, Regulatory Software & Services -
November 28, 2019 Regulatory Software & Services, Regulatory Affairs, Publishing & SubmissionsDrug development is an extensive and multifaceted process. In each phase of the development, manufacturers are obliged to demonstrate the safety and efficacy of their drugs in the form of Regulatory submissions. These submissions are intended to report how drug companies manufacture their drugs, design clinical trials, report safety findings, and create promotional material.
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December 27, 2018 Regulatory Artwork Services, Food and Food Supplements, Compliance, Audit and Validation, Consumer Healthcare, Cosmetics Regulatory Services, Medical Devices, Pharmaceutical, Registration Strategy, Regulatory Intelligence, Regulatory Labeling, Regulatory Software & Services, Regulatory Affairs, Market Access, Regulatory Consulting, Publishing & Submissions, Regulatory Medical Writing, Health Authority UpdatesThe life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.
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November 16, 2017 Regulatory Software & ServicesAs popularly known, IDMP (Identification of Medicinal Products) can be defined as a set of common global standards and technical specifications of data elements, formats and terminologies that enable unique identification and exchange of medicinal information.
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August 1, 2017 Regulatory Labeling, Regulatory Software & ServicesIt’s been almost a year since we’ve reported that Therapeutic Goods Administration (TGA) is on its way to impose new labeling requirements.
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Identify the best suited software ahead of time
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June 16, 2016 Regulatory Software & Services, Health Authority UpdatesTimes when patients are going through serious / immediately life-threatening conditions and physicians are left with no options except to opt for the investigational treatments, navigating certain processes would be challenging and time-consuming.
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IDMP has continued to be a hot topic in the pharma regulatory industry lately. It was expected that, in less than a month, EMA (European Medicines Agency) would want companies to start utilizing the defined terminologies to be submitted from July 1st2016. However, this has been further delayed according to the other industry sources.
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May 26, 2016 Regulatory Software & Services, Health Authority UpdatesIn a general scenario, it is important to share the clinical trial analysis to increase the scope of further research and transparency in the flow of information. However, there are different levels of information that needs to be distributed to the public.
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The EudraVigilance Medicinal Product Dictionary (EVMPD) has undergone several changes and enhancements since its inception in the year 2005 until now. EVMPD has been revised and is now known as XEVMPD with enhancements that include increase in the data to be captured, revised controlled vocabulary and submission criteria.