Capabilities:

• Reviewing pre-IND and IND packages prior to submission to minimize regulatory roadblocks.

• Interpreting FDA preliminary comments and meeting minutes to produce informed recommendations on next steps.

• Reviewing FDA submissions prior to filing to reduce regulatory burdens on both Applicant and FDA.

• Providing guidance to clients during NDA review process, including preparation for Advisory Committees.

• Strategizing with clients in support of most optimally time/cost efficient consumer development programs.

• Recommending tactics to partner productively with FDA.

• Training new/existing staff on consumer behavior regulatory studies.