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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.
In July 2022, the United States Food and Drug Administration (US FDA) issued draft guidance titled ‘Human Prescription Drug and Biological Products - Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers - “Dose Banding.” It is to help sponsors include dose banding information in dru
A drug therapy regimen is diverse for drugs that can be approved to be used in combination with a previously approved drug or simultaneously developed two novel drugs, that synergistically enhance efficacy. Single-drug cancer therapies significantly showcased drug resistance as a major threat for patients undergoing treatments with anti-cancer drugs.
As the world is moving towards digital transformation, the introduction of various tools is empowering many industries, including Pharmaceuticals and Life Sciences. In fact, the serialization and traceability of items can be improved even further as the world transitions to a digital economy.
In the era of personalized medications, precision medicine revolutionized the delivery of biologicals, ensuring safety and efficacy by comprehending the product’s effect at an individual level.
A Summary of Product Characteristics (SmPC) is an easy-to-access and product-specific resource enclosed with all the essential information about a product. The document includes the forms, clinical parameters, and pharmacological properties written and updated by organizations depending on their research and knowledge of a specific medicinal product.
In 1999, the European Medicines Assessment Agency (EMEA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) set out to design a new system to share product information electronically to support the submission of new products or variations post-approval. This was called Product Information Management (PIM), which was withdrawn in 2011.
To market medicinal products in the European Union (EU) countries, pharmaceutical companies must prepare and translate documents like the Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs), and product labels in twenty-four (24) EMA-approved languages.
In-depth analyses will highlight how pharmaceutical packaging, labeling, serialization, tracking, and traceability enhance consumer safety and transparency in the supply chain, as well as benefit pharmaceutical packaging that go beyond compliance with laws.
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.
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.
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