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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.
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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.
Labeling is an integral part of marketing medical devices. The label is a piece of information affixed with the device and/or packaging in a human-readable format. The main purpose of labeling is to provide safety information to users who can be healthcare professionals, consumers, or any other relevant person.
The US Food and Drug Administration (US FDA) has proposed to amend the medical devices Quality System Regulations (QSR) under 21 CFR 820. The current QSR regulations date to 1978 and have been amended only once in 1996.
In 1999, the European Medicines Assessment Agency (EMEA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) set out to design a new system to share product information electronically to support the submission of new products or variations post-approval. This was called Product Information Management (PIM), which was withdrawn in 2011.
To market medicinal products in the European Union (EU) countries, pharmaceutical companies must prepare and translate documents like the Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs), and product labels in twenty-four (24) EMA-approved languages.
Recently, the FDA published three (03) guidance documents that focus on generic drug application submissions, labeling, and review. Among the three (03) guidance documents, two (02) are final drafts, and one (01) is a revised draft, which supports FDA’s Drug Competition Action Plan (DCAP) that was first announced in 2017.
With technological advancements, the adoption of wireless medical devices for patients and healthcare management is growing at a fast pace. It is anticipated that four (04) out of ten (10) medical devices installation will be wireless or portable by 2031, and the wireless portable medical device market is expected to reach USD 33 billion.
With the dynamic landscape and the new reality due to the pandemic, the chemical industry has undergone a huge shift in demand. In the chemical market, the end of life for certain materials can start something new. Implementing a series of targeted, strategic initiatives across major functional areas can help manufacturers cater to short term demands.
The Health Ministry of Thailand strives to maintain the optimum quality of life and takes all the necessary measures to assure the health and safety of its people. Recently, the TFDA has amended the medical device regulations to meet the highest safety standards and quality of devices entering the Thailand market.
Communication effectiveness across the marketing platforms is evaluated primarily based on how well the content engages the audience or, in the case of brands, the consumer. In healthcare, the information available on these platforms is diverse.
Labeling has paramount importance in the medical device industry for ensuring high standards of quality and safety. The labels help educate the end-users or patients about how to use the device, who should use it, how to operate the device safely and what risks it could pose.
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