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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 device industry is undergoing continuous transformation to comply with the ever-changing Regulatory guidelines introduced by global Regulatory authorities to ensure strict controls over device performance and safety.
The COVID-19 pandemonium demanded Regulatory agencies to set forth certain amendments and measures for smooth functionality of review programs and product approvals. At the same time, the pandemic has encouraged health authorities to take precautionary steps in Regulatory communications and meetings with all the stakeholders.
Ever since the World Health Organization (WHO) has declared the COVID-19 outbreak as a pandemic, the global health authorities and life sciences organizations are quickly responding to the situation to see how they can make meaningful contributions.
Over the past few decades, Pharmacovigilance (PV), has been instrumental in detecting, assessing, understanding and preventing adverse events. In the due course, drug manufacturing organizations have implemented safety and PV systems with due diligence to stay compliant with Health Authority (HA) requirements.
Regulatory functions such as submission and publishing, regulatory intelligence, labeling, etc. are intricate areas of the regulatory spectrum that are ever evolving. There is no doubt to the fact that some real time challenges are involved in submission processes especially now when the world is shifting from paper to electronic submissions.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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