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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.
Artwork is a powerful branding tool in the pharmaceutical industry as it helps organizations create the correct brand perceptions. A survey conducted in late 2017 revealed that 60% of consumers are...
During the COVID-19 pandemic, Real-World Data (RWD) and Real-World Evidence (RWE) were essential sources of information for the United States Food and Drug Administration (USFDA) to expedite the approvals of COVID-19 vaccines and therapeutics and to allow other clinical studies to progress under the changing circumstances. For post-approval studies currently, the FDA ensures the...
The Food Safety and Standards Authority of India (FSSAI) released a Draft Notification on September 14, 2022, amending the Food Safety and Standards (Labeling & Display) Regulations, 2020. These regulations may be called the Food Safety and Standards (Labeling & Display) Amendment Regulations, 2022. It shall come into force on the date of their final publication in the Official...
The National Medical Products Administration (NMPA) of China recently released a comprehensive draft amendment for implementing the China Drug Administration Law (DAL).
The draft amendment introduces significant changes to the Regulatory framework. It encodes the various Regulatory initiatives undertaken by the Chinese government since the implementation of the current China DAL...
According to the CMDh practical guidance for Marketing Authorization Holders (MAHs) of nationally authorized products, the evaluation of nitrosamine impurity or cross-contamination in a marketed product is a critical criterion. Nitrosamines are proven to be carcinogenic and can affect the overall output of the formulated product.
Considering the severity, the Co-ordination group for...
Advance Therapy Medicinal Products (ATMPs) are novel drugs that meet patients’ specific needs. But they drastically increase the cost of treatment. Generic alternatives provide relief in terms of treatment cost with a quality drug of similar effectiveness.
A complex generic product is generally similar to brand-name generics. However, there are differences between the two (02) in...
In the European Union (EU), the promotion of medicinal products is governed by advertising laws and regulations. Particularly, the Directive 2001/83/EC of ‘the European Parliament and of the Council of 6 November 2001, on the Community code relating to medicinal products for human use,’ establishes the European Regulatory framework, which contains articles dedicated to promotional activities...
Regulations stand crucial for any industry that functions in the Life Sciences domain, which is the third most heavily regulated sector after the Aviation & Financial sectors. Non-compliance with regulations comes at a high cost – the patients’ lives, heavy economic penalties, or loss of reputation. But challenges to this sector comes from various areas.
On one hand, the...
Heavy metals are ubiquitously present in the environment surrounding us. Heavy metals containing ingredients such as thimerosal (mercury) and lead acetate were used as cosmetic ingredients in the past. They were also used as reaction catalysts during chemical synthesis and for manufacturing industrial equipment, containers or closures.
These heavy metals can be found as impurities (...
As public awareness of environmental issues is increasing rapidly, many cosmetic companies are engaging their focus on natural and environment-friendly emulsifiers and chemicals to be used in their products. The advantages of ‘green’ beauty products go beyond fashion. Newer research approaches have outlined the amount of toxicity in conventional cosmetics. However, it has been observed that...
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