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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.
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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.
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.
Pharmaceutical advertising, including direct-to-consumer advertising, is regulated by the United States Food and Drug Administration’s (US FDA) Office of Prescription Drug Promotion (OPDP), Advertising and Promotional Labeling Branch (APLB) at the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) respectively. The information submitted...
When the COVID-19 pandemic was first recognized as a global health crisis in 2020, global Health Authorities (HAs) took innovative steps to deal with it in the best possible manner. Likewise, pharmaceutical companies came up with several vaccines/medicinal products for the benefit of the public. However, registering the products turned out to be quite challenging. To simplify the registration...
Food labeling claims in the USA can differ based on factors like types of claims, the product of interest, and usage. They are also different for animal food, human food, and dietary supplements. The regulations and scientific standards ensure the labeling claims for food and food supplements are mentioned correctly and substantiated scientifically.
Understanding the Regulatory...
In the wake of COVID-19, deploying remote audit techniques is rising in the Life Sciences industry. With the imposed travel restrictions across the globe, medical devices, biotech, pharmaceuticals, and other life sciences organizations are turning towards virtual or Remote audits. The remote audit is carried out by utilizing video conferencing auditor and auditee and other software/web...
Singapore’s Health Sciences Authority (HSA) has published a guidance document detailing the classification rules for In Vitro Diagnostic (IVD) medical devices. As per the general rule, Regulatory controls should be proportional to the level of risk associated with an IVD medical device. Therefore, the level of Regulatory control should increase with the increasing degree of risk, and hence...
Health Canada regulates cosmetics sold in Canada. Manufacturers selling cosmetic products in Canada must ensure that their product labels comply with the labeling requirements. Cosmetic labeling includes various information, but one of the most important parts of the labeling is ingredient listing, which informs the customers about product composition.
Writing a compliant ingredient...
Europe is the busiest region with evolving Regulatory landscape, as Brexit compliance, application of the EU MDR, transition to UKCA marking, and upcoming IVDR deadline take the front seat. All these dynamics have kept the Regulatory professionals on their toes. The UKCA mark came into effect on January 1, 2021, and the CE marked devices have a grace period until July 31, 2023, to eventually...
Canada’s food regulations ensure they have one of the safest food supplies in the world. They are always looking forward to understanding and acting according to the changes or emerging trends in the food sector that may affect how or what they regulate. Currently, Health Canada (HC) is planning to consult with Canadians on modernizing the food regulations. The agenda is to keep the food...
Labeling is a vital aspect when it comes to marketing the cosmetic products as it helps consumers understand accurate details of the product. In Canada, cosmetics and personal care products are regulated by Health Canada (HC). Cosmetic labeling is regulated by the Food and Drugs Act, the Cosmetic Regulations, and the Consumer Packaging and Labeling Act and Regulations.
It is mandatory...
For years, Regulatory publishing was done by manual tasks. Publishers used to work for hours formatting documents, generating Agency-compliant PDFs, performing quality checks, compiling documents for submissions, and troubleshooting issues related to submissions.
Moreover, pharmaceutical companies are under immense pressure to submit error-free documents within stringent timelines. The...
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