Industry Blog
The Due Diligence Playbook: How to Qualify Suppliers, CMOs, and Contract Labs for OTC Drug Products
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),
Why Supply Chain Quality Management Is Non-Negotiable for OTC Drug Manufacturers
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
MoCRA in 2026 Made Simple
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
Top 3 Takeaways from Our “Launching an OTC Product” Webinar
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
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