ii dmfs filed in ctd-q format, the fda expects module 2. drug substance type ii dmfs for drug substances may be submitted in the format for "drug substance" in the "guidance for industry m4q: the ctd - quality".(category 3) drug substance: see the current guideline for submitting supporting documentation in drug applications for the manufacture of drug substances. it is not necessary to include a methods validation package (3.2.r.3). methods validation information should be submitted in section 3.2.s.4.3.