Know what the FDA thinks.

Practice areas

Two ways teams work with us.

Defensible donor eligibility determinations — screening, testing, and documentation reviewed against FDA expectations.

Former-FDA review of your INTERACT, IND, and expedited-program packages, by reviewers from CBER.

FDA meetings & filings

Former-FDA review of the package behind every formal FDA interaction.

INTERACT

Pre-submission INTERACT package review to surface the questions and deficiencies the FDA is likely to raise — before your meeting.

Pre-IND

A second pair of former-FDA eyes on your Pre-IND briefing package, with a clear read on alignment and the gaps to close.

IND

Full IND submission review against precedent and current FDA expectations, validated by a former reviewer in your product type.

Designation strategy

Strategy and supporting packages for the FDA's accelerated pathways.

RMAT

Regenerative Medicine Advanced Therapy designation — strategy and the evidence package that holds up the claim.

Breakthrough Therapy

Breakthrough Therapy requests built on preliminary clinical evidence of substantial improvement over available therapy.

Fast Track

Fast Track designation strategy for therapies addressing a serious condition and an unmet medical need.

Section 361 vs 351

Confirm how your cell- or tissue-based product is regulated — before the FDA does.

TRG Submission

Tissue Reference Group requests to confirm whether your HCT/P is regulated under Section 361 or 351 — framed the way FDA expects to see them.

Donor Eligibility

Donor eligibility determinations — screening, testing, and documentation under 21 CFR Part 1271 — reviewed against current FDA expectations.