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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 medical devices industry is considered as highly regulated. Hence, devising a right Regulatory strategy will be a potential approach and a great value-added contribution to avoid Regulatory roadblocks.
While the world is tussling with COVID-19 pandemic, there’s an emergency need for its treatments and vaccines. Though, currently, there is no FDA approved therapy or vaccine for COVID-19, the agency has several tools to expedite the review and approval of a COVID-19 biologic treatment or vaccine, after it emerges.
Registering a medical device with the FDA requires an apt submission pathway. In most of the cases, identifying and selecting a pathway is quite simple. For example, as discussed in our previous blog, if there exists a predicate for your medical device, then file a 510(k).
It’s no strange for everyone who is into regulatory intelligence services that a well-proportioned regulatory strategy plays a key role in boosting the opportunity of regulatory approval.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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