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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.
It is crucial for Regulatory bodies to monitor the vast range of consumer products available in their market. With new products entering the market regularly, this task becomes increasingly complex for Regulatory Authorities. However, it is important to detect potentially harmful products to ensure product compliance and consumer safety.
The year 2020 has been unpredictable for all the industries across the globe, including life sciences industry. With the outbreak of COVID-19, the life sciences industry and global Health Authorities faced various challenging scenarios, which in turn affected their long-term Regulatory plans.
The year 2020 was a roller coaster for everyone across the world. With the outbreak of the COVID-19, global Health Authorities (HAs) have been working relentlessly to ensure that healthcare professionals and the general public have the best resources to fight this pandemic.
On July 1, 2020, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) was officially replaced by the Australian Industrial Chemicals Introduction Scheme (AICIS).
As we look at these challenging times for manufacturers across the life sciences industry, of course, not in terms of manufacturing products, but to market them across the globe compliantly, we understand there is a dire need for effective Regulatory solutions and services to ensure products compliant market entry.
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.
About a year after issuing the final rule for antibacterial soaps, where it has banned 19 ingredients, the US Food and Drug Administration (FDA) has come out with an announcement on similar lines.
In a recent announcement, the Food and Drug Administration (FDA) has established that the antiseptic wash products with certain (19 in number) active ingredients can no longer be marketed.
Pharmaceutical and medical device industries are constantly changing with developing supply chain themes and technological advancements due to which labeling must be looked upon with a new perspective. A host of latest trends have compelled Pharmaceutical and medical device industries to rethink, strategize and streamline processes, meet compliance norms and start and learn best practices.
Ever since the eCTD submission became mandatory by FDA in 2008, the life sciences industry has been facing certain difficulties in regulatory processes. Even though the electronic common technical document has been of great help in managing huge volumes of important documentation; there are a few glitches that complicate the submission process for the organizations.
North America
South America
East Europe
Europe
North Africa & Middle East
Southern Africa
APAC
Australia & New Zealand
Japan & South Korea
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