Convergence of regulatory frameworks surrounding cell, tissue, and gene therapy products All Category, Insights, Regulatory / development Convergence of regulatory frameworks surrounding cell, tissue, and gene therapy products Read More »
An overview on the analytical assessment techniques for biosimilar development All Category, Blogs / development An overview on the analytical assessment techniques for biosimilar development Read More »
Challenges in immunogenicity assessments for biosimilar development All Category, Blogs, Medical Writing / development Challenges in immunogenicity assessments for biosimilar development Read More »
Differences in the regulatory pathways for biosimilar development: EU vs USA All Category, Blogs / development Differences in the regulatory pathways for biosimilar development: EU vs USA Read More »
US FDA draft guidance: Sameness Evaluations in an ANDA for active ingredients All Category, Blogs / development US FDA draft guidance: Sameness Evaluations in an ANDA for active ingredients Read More »
A summary of the “Guidance on the licensing of biosimilar products”- UK MHRA All Category, Blogs / development A summary of the “Guidance on the licensing of biosimilar products”- UK MHRA Read More »
An overview on some key regulatory challenges in API manufacturing All Category, Blogs / development An overview on some key regulatory challenges in API manufacturing Read More »
Solutions and best practices in eCTD Publishing and submission management All Category, Blogs, Publishing / development Solutions and best practices in eCTD Publishing and submission management Read More »
Challenges in eCTD Publishing & Submission Management All Category, Blogs, Publishing / development Challenges in eCTD Publishing & Submission Management Read More »
Adalimumab as a treatment choice for Rheumatoid Arthritis- a pharmacoeconomic perspective All Category, Blogs / development Adalimumab as a treatment choice for Rheumatoid Arthritis- a pharmacoeconomic perspective Read More »