Firstly, it’s important to determine a biological product’s category, the route for registration, and associated data requirements at the earliest opportunity. But a varied and changeable global picture for biologicals means this is far from straightforward.
In this article, five of Sagentia Regulatory’s formerly TSG Consulting’s, regulatory experts share insights on the product registration challenges companies typically face in North America and Europe, and how to resolve them. Their aim is to facilitate cost-effective and efficient national and global regulatory strategies for biological products.
