Combination products manufacturers face arguably the most misunderstood and misapplied regulatory requirements within the life sciences sector. Our experience suggests that combination products manufacturers of all sizes still struggle with the challenges imposed by 21 CFR Part 4 and related regulations and standards when addressing combination products requirements within traditional pharmaceutical, biopharmaceutical and medical device manufacturing quality systems.
Regulatory Concept Transference
We have found that many companies struggle with regulatory concept transference – the application of similarly worded or intended regulatory requirements to a differently regulated product component or function. Our work in the combination products arena – even with clients with deep experience with one regulated product class – is that assuming compliance to requirements and expectations can be risky – and costly. Architecting a quality system that meets the primary regulated product class – and addresses the called-out provisions of Part 4 – is not simple and takes years of focus, training, and education.
Our Combination Products Consultants
Our combination products consultants bring an unmatched level of expertise and experience. 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.