Research-peptide DTC · regulated

Bio Prime Labs

Bio Prime is where we proved the compliance-led outbound system. Cold email reply rate hit benchmark-beating levels. Zero compliance events across thousands of sends. The thing that worked: compliance baked in from day 1, not bolted on after a warning.

2-4x

Reply rate vs industry

Compliance violations

Sustained

Domain reputation

Before

What the setup looked like.

Regulated category. Previous agency: ran generic ad sets with overclaim language. Got FTC-warning-adjacent complaints. Two cold-email domains burned (spam complaints, blacklisted). We were paying for outbound that wasn't legal and wasn't working.

What we installed

Phase 01 — 3 compliance gates per draft

Every cold email passes CAN-SPAM + FTC + FDA prompt checks before queuing for approval. Auto-rejects on high-severity violation.

Phase 02 — Voice-matched copy

Cold email v4 framework. 4 variants. Voice-scored against operator samples before send.

Phase 03 — Domain warmup discipline

Two fresh domains warmed for 21 days before any cold sends. Max 30/day per inbox at end of warmup.

Phase 04 — A/B variant tracking

Per-variant open + reply rate logged. Z-test winner-check fires weekly. Underperformers culled after 100 sends per variant.

Phase 05 — Dead-lead reactivation SMS

3-message sequence to lapsed customers. Same playbook as Flow, DTC-tuned timing.

The numbers

What moved.

KPI

Before

After

Delta

Open rate

Below baseline

Above industry baseline

Sustained 6+ months

Reply rate

Below baseline

2-4x industry

Compliance + voice combo

Spam complaints

Domain-burning

Below 0.1% threshold

No IP burn

Compliance events

FTC-warning-adjacent

Built inside the lines

The lesson

Most agencies serving regulated DTC try to 'be compliant' — meaning they add disclaimers after the fact. That works until a regulator does anything. We work the other way: build inside the lines from day one. The constraint is the feature.

Operator's own brand (NOT a Thresia client — proof of system in regulated DTC). Actual Thresia client case studies will be added as pilots close and clients consent to publication.

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