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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.
Unmet Medical Need (UMN) is one of the most pressing priorities of health systems. Constantly evolving science and technology around healthcare has harbored the potential to explore various therapeutic options. Health Authorities encourage innovative therapies that promise significant benefits to patients' quality of life.
In the face of COVID-19 emergency, the European Medicines Agency (EMA) established faster scientific advice, rolling reviews and accelerated assessments to expedite the development and approval of medicinal products. EMA’s foresight is to support the development and marketing authorization of safe, effective and high-quality therapeutics and vaccines at the earliest.
Lack of clarity on indications and uninformed usage of drugs and biological products may lead to unforeseen adversities, which might in turn affect manufacturers / sponsors through financial penalties and legal actions.
Between 10/1/2015 and 9/30/2016, the United States Food and Drug Administration (USFDA) through its system has issued almost 3905 483s to Biologics (84), Medical Devices (934), Drugs (691), and Food (2196) manufacturers. The number shows that there is significant rise in manufacturing violations when the health agency inspected respective facilities.
Draw a finite line
Are you geared up with blocked timelines and strategies for upcoming drug / cosmetic Regulatory mandate? Before deciding on your next task, recheck on the category of your product to be marketed. Is it a drug or a cosmetic? Draw a finite line and understand corresponding Regulatory implications and laws to ensure your marketing efforts won’t go in vain.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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