Brand communication is about conveying why a particular brand is a smarter option than the competitors in the marketplace. The Pharma industry is no oblivious to the same. Across the globe, due to the highly fragmented market space, communication becomes the whole and sole prospect to architecture any brand identity.
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July 22, 2021 Regulatory Medical Writing -
July 21, 2021 Regulatory Medical WritingIn an era of Type-Backspace-Enter, relying on the Ink-Paper-Print model especially amidst the global pandemic can be worrisome. Traditional brand communication becomes a difficult affair due to social distancing measures and hence, the society is adapting to the ‘New normal’. Brands across the globe have already adopted changing trends in communication aligning with various pandemic norms.
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July 8, 2021 Regulatory Medical WritingRegulatory writing discipline with its guidelines and regulations is considered complex. In addition, staying ahead of an ever-changing Regulatory environment for generic submissions and approvals is a tedious process.
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May 25, 2021 Regulatory Medical WritingProfound research with poor documentation may not achieve Regulatory approvals. Documenting each section of ANDA demands attentive preparations by medical writers, else the entire development and marketing strategy will be derailed. Besides research protocols, the regulations, restrictions, and legalities that govern scientific and medical information play a vital role in ANDA submissions.
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January 19, 2021 Regulatory Affairs, Regulatory Medical WritingClinical and nonclinical research programs demand the development of high-quality documents for timely submissions and approval of the drug product from Regulatory authorities. Medical writing plays a crucial role in drafting all the necessary documents right from drug development through submission and approval.
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August 20, 2020 Regulatory Medical WritingWith an aim to make anonymized clinical information in drug submissions and medical devices applications publicly accessible, Health Canada released a guidance document named as Health Canada's Public Release of Clinical Information (PRCI).
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January 22, 2019 Regulatory Affairs, Regulatory Medical WritingWhile 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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December 27, 2018 Regulatory Artwork Services, Food and Food Supplements, Compliance, Audit and Validation, Consumer Healthcare, Cosmetics Regulatory Services, Medical Devices, Pharmaceuticals, 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?