Bringing a biological or biotechnology product to market is a considerable challenge. First, you must ensure the overall development program is appropriate for the biotechnological nature of the product, and second you must identify suitable comparability strategies needed for post-approval changes to the product and its manufacture. It’s also critical to understand the regulatory terminology and requirements in different countries and regions.
At Kendle, our expert regulatory consultants are well-positioned to keep abreast of technical and legislative changes on biological and biosimilar products worldwide, and can help you in all phases of development and registration.