Combination product manufacturers face arguably the most misunderstood and misapplied regulatory requirements within the life sciences sector. Our experience suggests that manufacturers of combination products struggle with the challenges imposed by 21 CFR Part 4 and related regulations and standards when addressing combination product requirements within traditional pharmaceutical, biopharmaceutical, and medical device manufacturing quality systems.
Combination Products
The Language Gap
It is important to understand the challenges that arise when dealing with combination products. One of the main difficulties lies in applying the language regulations that are outside your typical product domain to a new combination product. This can lead to confusion and uncertainty regarding regulatory compliance. With our experience in navigating the complexities of FDA regulations, Compliance Architects is well equipped to bridge this gap. Our expertise allows us to translate and apply the necessary requirements among various domains, ensuring that your combination products meet all regulatory standards effectively and smoothly. Let us help streamline the regulatory process and facilitate the successful approval of your combination products.
Our Combination Products Consultants
Our consultants bring unmatched levels of expertise and experience to the combination products category. By applying our deep understanding of multiple regulated product classes, and ensuring well-architected, well-understood quality systems, we enable companies to confidently embrace combination products, achieving product line growth and improved patient outcomes.