Our staff has significant experience across all application types (IND, NDA, BLA, ANDA, DMFs, and Orphan Drugs) from pre-IND preparation & strategy to annual reports.
We have a comprehensive understanding of eCTD strategy and industry best practices.
We continuously monitor the regulatory environment, stay apprised of changes in regulations or guidance documents, and can advise your team accordingly.
Our staff combined has over 70 years of experience.
Our eCTD strategy services harness years of practical, real-world experience, ensuring industry-leading techniques and processes.