Blogs Dec 1, 2022Challenges in immunogenicity assessments for biosimilar developmentRead MoreNov 25, 2022Differences in the regulatory pathways for biosimilar development: EU vs USARead MoreNov 22, 2022US FDA draft guidance: Sameness Evaluations in an ANDA for active ingredientsRead MoreNov 17, 2022A summary of the “Guidance on the licensing of biosimilar products”- UK MHRARead MoreNov 15, 2022An overview on some key regulatory challenges in API manufacturingRead MoreOct 18, 2022Solutions and best practices in eCTD Publishing and submission managementRead More Previous1…333435…37Next Previous123Next
