Dr Asha Kattige
Dr Asha Kattige is Principal Consultant, Scendea
JournalRegulatory challenges and key considerations in the development of radiopharmaceuticals
This article looks at CMC, clinical and non-clinical considerations in the development of radiopharmaceuticals.
EditorialNavigating complexity: Regulation at the interface of innovation, technology and confidence
This issue focuses on complex products, with articles on brain-computer interfaces, radiopharmaceuticals and sophisticated generic products, and explores how regulatory systems can remain robust and predictable while enabling novel technologies to reach patients.
JournalConsiderations for generics developers moving into the field of biosimilars
Many generic developers have experience in both manufacturing and gaining US and EU approval for generics which are small molecule alternatives to the authorised original products. These developers possess the relevant skillsets to allow them to pursue the development of biosimilars, which are large molecule biologics highly similar to the authorised original products.