Industry Blog
The 10 Steps to Launching an OTC Drug the Right Way
Launching an OTC drug involves more than just mixing ingredients and designing a label. It requires strict adherence to FDA regulations and Good Manufacturing Practices (GMP). In our recent webinar,
Navigating the Minefield of Cosmetic Claims: A Decision-Tree Approach
On the health and beauty shelves, a compelling claim can be the difference between a bestseller and a product that gathers dust. However, the stakes for getting those claims wrong
What is an OTC Monograph and Why Is It Critical for Your Launch?
Launching an Over-the-Counter (OTC) drug in the United States is a rigorous process, but it doesn’t always require the years-long, multi-million dollar path of a New Drug Application (NDA). For
RIPT Testing Essentials: How to Validate Hypoallergenic Claims for Cosmetic Products
In today’s cosmetic and personal care product market, claims such as “hypoallergenic,” “suitable for sensitive skin,” or “non-irritating” are powerful differentiators. Consumers want products that are gentle, safe, and less
3 Testing Traps That Can Derail Your OTC Product Launch
Launching a new product is a high-stakes endeavor. You depend on testing data to validate performance, support claims, and satisfy regulators. Yet many companies stumble before they even get to
Photoallergy vs Phototoxicity Testing: Regulatory Guidelines & Best Practices in Photobiology Safety Assessment
In R&D, formulation, and for compliance teams working in cosmetics, personal care, or topical pharmaceutical products, understanding the differences between photoallergy and phototoxicity is essential to ensure product safety, meet
Why Cosmetic Brands Can’t Wait: The Asbestos-in-Talc and Fragrance Allergen Rules Under MoCRA Are Coming
Introduction: A New Era in U.S. Cosmetic Regulation The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most sweeping update to U.S. cosmetic legislation in decades. Among its
Understanding Dropping Point Testing for Sunscreen
When formulating sunscreen products, it’s essential to validate not only UV protection, such as SPF and broad-spectrum claims, but also thermal stability and performance under heat. Dropping Point testing is
Ensuring Consumer Safety: The Importance of Burkholderia cepacia Testing
Understanding Burkholderia cepacia: A Hidden Threat Burkholderia cepacia complex (BCC) comprises a group of Gram-negative, rod-shaped bacteria that are notorious for their opportunistic nature. These bacteria pose a significant health
Cosmetic Stability Testing: Why It Matters More Than Ever
Cosmetic Stability Testing: Why It Matters More Than Ever As consumers increasingly demand high-performing, long-lasting, and safe cosmetic products, stability testing has emerged as a cornerstone of modern product development.