A leading-edge provider of nuclear medicine and diagnostic imaging products and services based out of Australia reached out to Freyr for exclusive eCTD publishing services to support their major variation submissions in eCTD format. Located in various major countries around the world including China, Taiwan, Hong Kong, New Zealand and Australia, the Client has a therapeutic focus in Oncology and Cardiology. Initially Freyr was challenged to work with global teams in proceeding with Regulatory submissions support to multiple countries like US, CA, Europe, GCC, Australia, and ROW countries.
Read this case to decode how Freyr supported the client with sound knowledge on various region specific Regulatory variations.