Module 12 Presentations

Option3

• Using multiple 3.2.P.4 sections with 3.2.P.4.x granularity • One or multiple files can be submitted at the appropriate 3.2.P.4.x level per excipient CTD topic. • Multiple files at the same 3.2.P.4.x level (e.g. separate files for each excipient or grouping of excipients covering each of the 3.2.P.4.x topics) can be distinguished using informative eCTD Titles

The Organisationfor Professionals in Regulatory Affairs