The shift toward electronic labeling (e-labeling) and electronic Product Information (ePI) is no longer a distant future, it’s happening now. For Regulatory Affairs teams, this transformation brings both questions and opportunities. If you’re wondering what this shift means for your daily work, you’re not alone.
In a fast-scaling biotech environment, you’re managing regulatory documents, clinical content, labeling, instructions for use, artwork, and important safety information. These aren’t just words on a page, they’re the backbone of your product’s journey to patients, regulators, and partners. And every version must be accurate, consistent, and audit ready.
The FDA’s proposed front-of-package nutrition labeling represents one of the most significant food labeling changes in decades. This article introduces the proposed rule, countries that have already implemented it, and explores the economic and health benefits.
In the rapidly changing and highly competitive Fast-Moving Consumer Goods (FMCG) sector, labeling and packaging plays an important role in brand identity, over and above its purpose of protecting the physical product.
The pharmaceutical and medical device sectors are undergoing significant transformation. Faced with growing regulatory demands, the rapid pace of globalization, and higher market expectations, the pressure to deliver safe, effective products faster and more efficiently is now greater than ever before.
Quality management is a crucial element in any operations. However, it is especially important for regulatory affairs professionals in regulated industries such as pharmaceuticals and medical devices, as well as in fast-moving consumer goods sectors (FMCGs) like food and cosmetics. Quality assurance provides the basis for market approval, helping prevent quality lapses that could trigger compliance actions or endanger public safety.
Artwork approval is a crucial step for regulatory affairs (RA) professionals in labeling and packaging. Even minor oversights can lead to non-compliance, costly product recalls, and submission and product launch delays. To help navigate this complex process, we’ve compiled an essential artwork approval checklist that will streamline approvals, ensure compliance, and protect brand integrity.
Speed to market is king in the fast-moving world of consumer goods. Yet, countless hours are spent reviewing packaging artwork before going to market. Traditional review methods are time-consuming and prone to human error. A single mistake in an ingredient list or a barcode could result in lost sales or shelf space, a recall and damage to the brand reputation.
Pharmaceutical packaging plays a critical role in ensuring the safety, efficacy, and quality of medications. The US Food and Drug Administration (FDA) closely regulates packaging and labeling, as well as manufacturing processes in pharmaceutical packaging. Ultimately, these regulations and guidelines safeguard patient health.
Food labeling plays a crucial role in protecting consumer health by providing information relating to food sources, nutrition and safety. Accurate and informative food labeling allows consumers to make informed dietary choices. Compliance with food labeling regulations is not only a legal requirement but also impacts brand reputation.
