Onboarding · trial-readiness scoping

Tell us about the engagement.

Five short steps. We read every scoping dataset directly — no sales qual maze, no auto-responder. The assigned reviewer picks the case up from the engagement inbox and reaches back within two business days.

Scoping wizard

Five steps to a scoped engagement.

Each step gates the next — the wizard won't let you skip a required field. You can come back and edit previous steps from the review screen before submitting.

Scope · step 1 of 5

What kind of FDA workflow are you scoping?

Pick the engagement type that best fits the situation — reviewer support, inspection-readiness, or an AI system validation package.

Step 1: What kind of FDA workflow are you scoping?
Step 2: Tell us about the organization.
Step 3: When does this need to land?
Step 4: Who should the reviewer reach back to?
Step 5: Review and submit.

Engagement type

CRL responseComplete Response Letter resubmission for an IND / NDA / BLA / 510(k).Inspection-readinessFDA pre-approval or surveillance inspection — gap analysis + SOP/V&V posture.AI validation21 CFR Part 11 / GMLP validation log for a model or AI subsystem.

Scope notes

At least one to two sentences (40+ chars) — the reviewer reads scope notes directly while sizing the engagement.

Severity classification

Lowminor clarification, no clinical holdMediumtitled deficiency, no clinical holdHighmajor amendment, label impactCriticalclinical hold or refusal-to-file

Same lowercase enum the CRL response + inspection-readiness workbenches use — keeps severity joins stable across surfaces.

Related surfaces

Other ways in.

The wizard is the trial-readiness intake — for a three-question starter intake, see /start. For the audit-grade posture behind every Tallymark FDA engagement — five engagement documents that hold every reviewer-signed deliverable to the same standard — see our compliance posture.

Start the trial-readiness record →