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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.
During the COVID-19 pandemic, Real-World Data (RWD) and Real-World Evidence (RWE) were essential sources of information for the United States Food and Drug Administration (USFDA) to expedite the approvals of COVID-19 vaccines and therapeutics and to allow other clinical studies to progress under the changing circumstances.
The National Medical Products Administration (NMPA) of China recently released a comprehensive draft amendment for implementing the China Drug Administration Law (DAL).
Advance Therapy Medicinal Products (ATMPs) are novel drugs that meet patients’ specific needs. But they drastically increase the cost of treatment. Generic alternatives provide relief in terms of treatment cost with a quality drug of similar effectiveness.
In the European Union (EU), the promotion of medicinal products is governed by advertising laws and regulations.
Social media and other communication technologies are excellent instruments for bringing attention to public health issues and solutions. In addition, these contemporary tools are employed to disseminate misinformation and conspiracies regarding various subjects, such as vaccinations, genetically engineered organisms, climate change, and, most recently, the COVID-19 pandemic.
The 510(k)-clearance program, also known as Pre-Market Notification (PMN), is US FDA’s device review pathway to ensure safe and effective entry of medical devices into the US territory. US FDA requires manufacturers of the majority of Class II devices and a few Class I and III devices to obtain 510(k)-clearance.
Labeling is an integral part of marketing medical devices. The label is a piece of information affixed with the device and/or packaging in a human-readable format. The main purpose of labeling is to provide safety information to users who can be healthcare professionals, consumers, or any other relevant person.
The rise in Tracking and Tracing (T&T) systems in the pharmaceutical industry can be attributed to the development of novel and patient-centric medicines. Over the years, T&T systems have improved medication for patients by transforming product handling processes without a quality compromise until it gets dispensed by integrating supply chain operations and technology use.
The US Food and Drug Administration (US FDA) has proposed to amend the medical devices Quality System Regulations (QSR) under 21 CFR 820. The current QSR regulations date to 1978 and have been amended only once in 1996.
Companion Diagnostics (CDx) are In Vitro Diagnostic devices used in conjunction with therapeutic drugs to determine their suitability for the patients. To place the CDx in the European Union, the manufacturer is required to submit technical and other relevant documents to the Notified Body (NB) for technical and conformity assessment.
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