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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.
Regulations stand crucial for any industry that functions in the Life Sciences domain, which is the third most heavily regulated sector after the Aviation & Financial sectors. Non-compliance with regulations comes at a high cost – the patients’ lives, heavy economic penalties, or loss of reputation. But challenges to this sector comes from various areas.
Introducing innovative products across global marketplaces is imperative for life sciences companies to ensure profitability and maintain their presence in the market. Regulatory compliance and authorizations being the key factors behind any winning launch, inadequate Regulatory information can trigger an increase in costs and time-to-market.
Life science companies face massive challenges while constantly staying ahead of dynamic Health Authority (HA) updates. In addition, it requires multiple recurring and time-consuming processes. The traditional exercises are cumbersome and laborious, proving that Regulatory operations are costly, complicated, and slow.
Hair colorants are classified as cosmetic products by the European Commission (EC) and are regulated under the regulation (EC) No: 1223/2009. Hair colorants contain a mixture of substances called hair dyes that are used to change the color of hair or to restore the original hair color. They are classified into the following three (03) categories based on their color fastness:
Sustaining the ever-evolving global Regulatory space of the life sciences industry is strenuous. Therefore, it is necessary for manufacturers to keep abreast with the latest Regulatory information to ensure compliance across all the business functions, such as clinical development, release, and marketing scrutiny of medicines.
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.
Wide range of food products, dietary supplements and other health foods that are consumed to enhance the nutritional value of food are constantly growing, worldwide. All combined can generally be termed as nutraceuticals.
Wading through uncharted waters is always risky and mount numerous pressures on organizations. It not only affects organization’s financial status quo but also impose threat to brand image. If it is the same in the life sciences sector, the situation may lead to incompliance and untimely drug approvals thus posing a threat to patient safety.
Regulatory being such a vast field of operations, often tend to create confusion for what means what. One of the most dominant services of regulatory consulting that often arrives with misapprehensions is Regulatory Intelligence (RI).
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