For R&D, formulation, and regulatory professionals evaluating their safety testing programs, the shift toward in vitro methods is no longer a trend. It’s the established standard. 1. Regulatory frameworks have already moved in the EU and across the U.S. Animal testing restrictions for cosmetics are not pending legislation. The European
Whether you are testing raw materials, in-process samples, or finished goods, the right compendial method depends on your product type, formulation, and regulatory market. Here’s a working overview. 1. USP <61>: Microbial Enumeration USP <61> is the foundational compendial method for quantitative microbial enumeration, measuring Total Aerobic Microbial Count (TAMC),
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,
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
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.
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.
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
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For R&D, formulation, and regulatory professionals evaluating their safety testing programs, the shift toward in vitro methods is no longer a trend. It’s the established
Whether you are testing raw materials, in-process samples, or finished goods, the right compendial method depends on your product type, formulation, and regulatory market. Here’s
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
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
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
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
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