In regulated industries, content verification has become a business-critical function.
Regulatory scrutiny is increasing. Product portfolios are growing. Content is more complex and multilingual than ever before.
In regulated industries like pharma, medical device, fast-moving consumer goods (FMCG), and crop science, documentation isn’t just part of the process — it is the process. It’s what stands between your product and the market, your team and regulatory approval, your brand and consumer trust.
With the FDA’s proposed front-of-package nutrition labeling rule now on the horizon, the food industry is preparing for one of the most significant packaging changes in recent years. While our previous blog explored what this regulation entails and its global precedents, the critical question now becomes: who exactly will this impact, and how?
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.
