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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.
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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.
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.
One of the most recent amendments applied in the year 2020 for the labeling compliance of food and drinks is the update of the Nutritional Facts Panel by the United States Food and Drug Administration. It is solely based on scientific information, new nutrition research, and various other inputs from the public. The amendment has been made by taking certain factors into consideration, most...
It is well known that from January 1, 2021, medical devices to be placed on the UK market are obliged to follow a new Regulatory regime. Currently, the UK market is a witness to many Regulatory changes, with the impact of Brexit. The UK’s existing Regulatory Authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), has taken over the European Union (EU) responsibilities,...
We all are aware of how food and medicine are different in terms of how they individually nourish the body, but both eventually tend to mainly assist in maintaining our health. While we are trying to enhance our immunity, improve our stamina or deal with current chronic health concerns, we sometimes tend to buy unknown food and food supplements, with poor labeling, which can cause more harm...
ANVISA of Brazil received the approval to become a member of PIC/s (Pharmaceutical Inspection Co-operation Scheme) in November 2020. Considering the pandemic situation, for the first time in PIC/s history, the assessment was completed in a written procedure as opposed to at a meeting; on Jan 1, 2021, the PIC/s committee welcomed ANVISA as their 54th valuable member.
The other 53...
Maintaining a Quality Management System (QMS) is the foundation to demonstrate Regulatory compliance in the medical devices industry. QMS is a structured system of procedures and processes, covering all the aspects of design, manufacturing, risk management, supplier management, complaint handling, clinical data, storage, distribution and product labeling of medical devices. To meet the...
Supply Chain, Packaging and Artwork Management System - In Life Sciences, any delay or mishap in the latter two segments will affect the former which results in product not reaching the markets on time and thus leading to heavy cost burden on the companies. As a crucial step towards smooth functioning of supply chain, packaging must not only be done at the right time and right...
National Medicines Regulatory Authority (NMRA) of Sri Lanka has declared the ‘List of Countries’ to be exempted from the manufacturing site audits. Essentially, this list refers to the respective health authorities in the specified countries, also termed as ‘’Reference Countries.’’ The health authorities included in the list are:
In the context of COVID-19, there is an increasing interest in understanding the PPE regulations. To meet the growing interest, TGA the Australian Regulatory Authority has issued a guidance, which covers an overview of how PPEs are regulated, information for PPE manufactures and the PPE standards.
Overview of PPE Regulation: As per the item 2A of Schedule 1 of the...
Under the Classification, Labeling and Packaging of substances and mixtures (CLP) regulation, Chemical companies, who wish to place hazardous chemical mixtures such as paints, coatings, detergents, solvents, etc. in the European market are required to provide notifications of the hazards in their products. Poison centres take the responsibility to collect relevant information about hazardous...
Environmental Protection Agency of the US is prioritizing the attempts to develop and use New Approach Methods (NAMs) for chemical testing. This new approach will help in reducing the usage of animals as subjects in chemical testing while ensuring the protection of human health and the environment. NAMs are equivalent to “alternatives" to animal testing.
The EPA has a broad range of...
North America
South America
East Europe
Europe
North Africa & Middle East
Southern Africa
APAC
Australia & New Zealand
Japan & South Korea
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