Regulatory complexity within the OTC drug, cosmetic, and dietary supplement space is intensifying. Here’s how CPT℠ Labs’ consulting services help manufacturers and brands get ahead of it. 1. FDA compliance remediation that addresses the “root cause”, not just the citation point. When a FDA 483 observation or Warning Letter arrives,
Sunscreen brands are under more scrutiny than ever. Between FDA scrutiny, retailer expectations, consumer watchdog testing, class-action lawsuits, and viral social media callouts, inaccurate SPF claims can quickly turn into a regulatory, legal, and PR nightmare. The challenge is that many brands don’t realize there’s a problem until it’s already
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
Bringing an Over-the-Counter (OTC) drug to market is a high-stakes endeavor. If you missed our live webinar about Launching an OTC Product the Right Way, here are the three most critical takeaways that every brand owner needs to know and how to avoid the most common pitfalls that delay launches
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, Bill Neumann, VP of QA and Regulatory Affairs, outlined a logical, 10-step process to ensure a compliant and efficient launch.
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
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 most OTC products, the pathway to market relies on the OTC Drug Monograph system. But what exactly is it, and
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.
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Regulatory complexity within the OTC drug, cosmetic, and dietary supplement space is intensifying. Here’s how CPT℠ Labs’ consulting services help manufacturers and brands get ahead
Sunscreen brands are under more scrutiny than ever. Between FDA scrutiny, retailer expectations, consumer watchdog testing, class-action lawsuits, and viral social media callouts, inaccurate SPF
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
Bringing an Over-the-Counter (OTC) drug to market is a high-stakes endeavor. If you missed our live webinar about Launching an OTC Product 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
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
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
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