eCTD-COMPLIANT PUBLISHING & SUBMISSIONS

The common technical document (CTD) is a globally accepted submission format developed by the International Council for Harmonization (ICH). In this whitepaper, we'll discuss the structure and different modules used, formatting when writing applications, and additional considerations. 

 

FDA Regulatory Consulting

 


 

 

Antony Kaprielian - Gradient

Antony Kaprielian, Regulatory Operations Manager

With over 5 years regulatory experience, Antony manages the company’s in-house regulatory operations team, covering all regulatory submissions from early- to mid-phase FDA applications. He also publishes all eCTD submissions to ensure they meet both agency and company standards. Located in Virginia, Antony is also a jazz musician and nature photographer in his spare time.

 


 

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