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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.
Medical device Post Marketing Surveillance (PMS), an important practice in the entire pharmacovigilance activity, is the process of ensuring the continued safety and efficacy of the device after it is approved and marketed. When the medical device is launched in the market, it is used by a large number of the general population with various medical conditions.
You might be aware, in the context of pending agreements between Switzerland and the EU, there are certain modifications/amendments made to the Medical Devices Ordinance (MedDO) and the Federal Council approved supplementary provisions for implementing medical device regulations, which are in force since May 26, 2021.
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