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Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.
Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.
The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.
The Committee on Publication Ethics (COPE) was established in 1997 to address research and publishing ethics violations. Its goal was to identify workable solutions to the problems and create best practices. It is a non-profit organization that offers a discussion forum and guidance to scientific editors.
Drug Development Technologies (DDTs) are methods, materials, or measures that assist in drug development and Regulatory review, as stated in the 21st Century Cures Law. These include biomarkers, clinical outcome evaluations, and other metrics.
The pharmaceutical and Life Sciences sectors have seen a steady increase in the need for Medical Writing. Patents have been expiring, Regulatory standards have changed quickly, and spending on research and development has been rising constantly. Because of this, the necessity to continuously adapt, produce, maintain, and update medical material has evolved.
Child-resistant Packaging (CRP) is a type of packaging that is difficult for young children to open (or gain access to the contents) as opposed to adults. CRP reduces child mortality/adverse effects from the unintentional ingestion of oral prescription drugs.
The World Health Organisation (WHO) declared the Global outbreak of Monkeypox as a Public Health Emergency of International Concern (PHEIC) on July 23, 2022. A week later, on July 29, 2022, Brazil recorded its first fatality (the first death caused by Monkeypox outside of Africa), according to Brazil’s Health Ministry.
Medical writing refers to writing scientific documents by specific healthcare professionals for various purposes, including Regulatory submissions. The global medical writing market was valued at USD 3.6 billion in 2021 and is expected to reach USD 8.4 billion in 2030, growing at a CAGR of 10.41%.
It is challenging for medical writers to ensure that their project’s content, style, and format are high quality. Even the best medical writers may make a mistake. Therefore, it is important to have a quality check of the documents. Quality Control (QC) experts look at a document with a set of “fresh eyes,” which can identify mistakes that an author might overlook.
With an increasing number of new drug applications and clinical studies conducted to substantiate the efficacy and safety of new molecules, it becomes critical for pharmaceutical organizations to disseminate scientific information to the target audience via publication in a renowned scientific journal.
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