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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.
The use of face masks is increasing due to the rapid spread of COVID-19. To meet the growing demand, different types of face masks are manufactured and released into the market, claiming to serve the medical purpose.
In the light of the international health crisis, on April 17, 2020, the European Commission (EC) proposed a one-year delay in the adoption of the new European Union Medical Device Regulations (EU MDR). Originally, the set of regulations were supposed to come into force by May 26, 2020.
The European Commission’s (EC) Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) have been the most significant developments for medical device manufacturers willing to enter the European market. These regulations will allow the EU (European Union) regulators to have the required control and oversight of the medical devices entering into the market.
Do you know? Excipients which are used in drugs, thought to be inactive, but in some circumstances, they may lead to severe reactions. To safeguard patients from such adversities, the European Medicines Agency (EMA) has updated its annex to the European Commission’s guideline on the labeling of five new excipients.
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APAC
Australia & New Zealand
Japan & South Korea
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