While researching for an innovative drug/device/cosmetic/food supplement, a huge amount of clinical data is expected to be generated. The conclusions of such data must be clearly reported with an appropriate level of detail to the health authorities (HAs). The information to be reported or documented might be research data, trial descriptions, findings, warnings etc.
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January 22, 2019 Regulatory Affairs, Regulatory Medical Writing -
December 27, 2018 Artwork Pack Management, Compliance, Audit and Validation, Consumer Healthcare, Cosmetics Regulatory Services, Medical Devices, Nutraceuticals/Food Supplements, 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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March 15, 2018 Regulatory Medical WritingFinished drug products contain minute amount of impurities which find their way into drugs at various junctures of manufacturing. They can be residual catalysts from synthesis or might get picked when in contact with manufacturing equipment, containers or other sources.
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October 18, 2017 Regulatory Medical WritingAre you a drug or biologics manufacturer willing to submit adverse event (AE) report with respect to your product to the United States Food and Drug Administration (USFDA)? Or are you a healthcare professional or a consumer planning to report AE or medication error to the US health agency and/or willing to access the safety information related to a specific drug?
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March 14, 2017 Regulatory Medical WritingMedical Writing industry is on an upward surge, mainly driven by an increasing demand in Emerging markets to have high-quality documents authored to support timely drug approvals. At the face of the demand, more than the perfection in the domain, organizations should focus on obtaining clarity on what exactly is medical writing than being confused with science writing.
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As the year-end is drawing nearby, it’s time to retrospect on all the Regulatory actions that the Pharma industry stood by to fall in compliance with Health Authority mandates. It is worthwhile to reflect upon the influential industry trends, HA guidance documents and major industry challenges that we’ve been covering in the last 12 months.
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March 22, 2016 Regulatory Affairs, Regulatory Medical WritingIn the first part of this series, we discussed what actually a medical writer does. In this segment, we will talk in detail about the process of medical writing.
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March 16, 2016 Regulatory Affairs, Regulatory Medical WritingThe stringent regulatory guidelines, uncompromising regulatory spectrum and need of high-quality clinical documentation for submission to authorities have made the regulatory medical writers an important cog in the wheel for regulatory service providers and CROs.
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June 16, 2015 Regulatory Affairs, Regulatory Medical WritingA Medical writer plays a prominent role in writing various non-clinical and clinical documents related to drug approval from health authorities, in order to bring it to the market for making them accessible to the customers. Medical writer needs to produce high quality documents in a short time.
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Can more than one drug name appear in a CCDS? Who is the proper party to approve CCDS updates and revisions?This articles offers a framework and helps in understanding the role of the cross-functional teams and their undertakings that are involved in creation of a CCDS.
In Perspective