Jump to navigation
Search
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.
Read More
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.
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.
To strengthen the cosmetic product regulations in South Korea, the Ministry of Food and Drug Safety (MFDS) introduced six draft amendments in 2019. The amendments focus on various Regulatory aspects of cosmetic products such as manufacturing, scrutiny, labeling etc. The purpose of proposing these amendments is to ensure the distribution of safe and effective cosmetic products in South Korea...
Brexit is just around the corner and the United Kingdom (UK) is all set to leave the European Union (EU). The implementation date of Brexit was yet again postponed to January 31, 2020, after the UK requested more time for preparations. However, if the UK and the EU are able to ratify a withdrawal agreement by the time of Brexit, the UK will have a transition period until December 31, 2020, to...
Thanks to the evolving global Regulatory landscape! Each country now has its own, defined regulations and requirements in governing the quality, safety, and efficacy of the medicinal products entering or being manufactured in their market. In this scenario, it is necessary for organizations to know about specific Regulatory requirements of their targeted markets. If their targeted market is EU...
Food safety has always been one of the top priorities of the United States Food and Drug Administration (USFDA). Strengthening it more, the agency is now shifting its focus from responding to foodborne illness to preventing it. To accomplish the same, as part of the FDA-track project, FDA has recently set up a Food Safety Dashboard to track the impact of the FDA...
It has been observed for long that innovation drives the life sciences industry, and this would continue perpetually. For the betterment of human health, there have been many innovative drugs/devices released into the market. For good, some of them shaped the humankind well, but alas some had to be taken off the market due to their adverse reactions and manufacturing and Regulatory procedural...
The United States Food and Drug Administration (USFDA), to enhance the submission process for medical devices, has introduced a final rule to replace the paper submissions with electronic submissions. The rule which was proposed in September 2018 is expected to come into effect in 2020. The final rule is aimed at improving the device's premarket submission program and targeted towards making...
Cosmetic claims are an integral part of any cosmetic label. They are a great marketing tool to help consumers make an informed choice amidst a range of similar products. To ensure that the users are well informed about the cosmetic products, the European Commission (EC) regulates cosmetic claims under Article 20 of the European Cosmetics Regulation No.1223/2009. The purpose of the regulation...
In 2016, the United States Food and Drug Administration (FDA) released final rules for the revised Nutrition Fact Labels, a part of which will be effective from the year 2020. It was initiated by the USFDA to help consumers make informed food choices and promote a healthy diet and lifestyle. As per the new nutrition guidelines, manufacturers with annual sales of more than USD 10 million or...
The changing landscape of the life sciences industry makes it necessary for the companies to adapt to the global Regulatory requirements, immediately. Companies need to evolve themselves for the necessary transition with each mandatory requirement from the health authorities. One such mandatory requirement in recent times is the Electronic Common Technical Document (eCTD) format, an electronic...
Malaysia is one of the leading markets in the cosmetics and personal care products industry. In 2019, the Malaysian cosmetics market was valued at USD 1.6 billion with a CAGR of 4.2%. According to the industry experts, the unprecedented growth of the industry is majorly a result of increasing population and employment levels, which are driving the consumers to be more conscious about the...
North America
South America
East Europe
Europe
North Africa & Middle East
Southern Africa
APAC
Australia & New Zealand
Japan & South Korea
Get Blog Updates Delivered Straight to Your Inbox
