In the OTC drug industry, your product is only as good as the partners who help you make it. The raw material supplier who sources your active pharmaceutical ingredient (API), the contract manufacturer (CMO) who blends and packages your product, and the contract testing lab whose results determine the release
If you’re involved in the manufacture or distribution of over-the-counter (OTC) drug products in the United States, you’re already operating in one of the most scrutinized regulatory environments in the world. Yet many companies, especially smaller brands and private-label manufacturers, treat supply chain quality as an afterthought rather than a
MoCRA in 2026: Where Things Stand and What You Should Have Done Yesterday When the Consolidated Appropriations Act of 2023 was signed into law on December 29, 2022, it ushered in the most significant overhaul of cosmetic regulation in the United States since 1938. The Modernization of Cosmetics Regulation Act
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 have never been higher. From regulatory bodies like the FDA and FTC to a single frustrated influencer who can derail
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 likely to cause adverse skin reactions. However, from a regulatory, scientific, and brand credibility perspective, such claims require solid evidence.
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 market. Below are three common “testing traps” that can silently undermine your launch readiness and what you should do to
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 regulatory requirements, and prevent adverse skin reactions. In this blog, we’ll review the relevant regulatory frameworks and discuss how we
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 many new requirements are mandates for standardized asbestos testing in talc and fragrance allergen disclosure. These mandates are not optional
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 a crucial analytical method that helps in R&D, formulation, compliance, and regulatory review. What is Dropping Point Testing? Dropping Point
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 risk, particularly to individuals with compromised immune systems, those who are mechanically ventilated, and patients with underlying conditions such as
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In the OTC drug industry, your product is only as good as the partners who help you make it. The raw material supplier who sources
If you’re involved in the manufacture or distribution of over-the-counter (OTC) drug products in the United States, you’re already operating in one of the most
MoCRA in 2026: Where Things Stand and What You Should Have Done Yesterday When the Consolidated Appropriations Act of 2023 was signed into law on
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
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
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
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
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
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
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