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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.
Most life sciences organizations find it difficult to streamline their Regulatory submissions process due to frequent changes in the submission guidelines. According to a recent analysis conducted by the United States Food and Drug Administration (USFDA), 32% of submissions with study data had critical data conformance issues.
On February 09, 2022, the European Medicines Agency (EMA) commenced the establishment of a Coordination Centre for Data Analysis and Real-World Integration Network (DARWIN EU®). It is the first step towards integrating Real-World Evidence (RWE) into assessing medicines across the European Union (EU).
Emergency Use Authorizations (EUAs) are significant in making life-saving medicinal products available to patients faster. They have been helpful in dealing with pandemics like COVID-19.
Based on the European Commission’s (EC) proposal on facilitating the movement of goods from Great Britain to Northern Ireland in October 2021, the Commission has now set up plans to maintain the medicines’ supply in specific markets post-Brexit.
Supply chain challenges across the globe have laid bare the inefficiencies of the distribution system framework amidst the pandemic. Considering its enduring impact on the global pharmaceutical market, better operational structure and resilient operational framework are the basis for seamless manufacturing requirements in hindsight.
The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.
The year 2017 was an eventful year for the Regulatory space, with several major happenings taking place across various industries such as: Pharmaceuticals, Biologics, Cosmetics, Medical Devices (MD) etc. While the MD industry witnessed the strengthening of MD regulations across the EU, the cosmetics industry saw advancements in the form of improved guidelines for cosmetic product safety.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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