Compliance & Risk — Launch Faster, Stay Safe
Outcome
- Fewer MLR cycles, fewer redlines. OPDP/APLB-ready workflows, templates, and pre-flight checks so creative, media, and web teams move quickly—while Privacy and PV have a defensible audit trail.
Who this helps
- (at a glance)
- Marketing Directors / Leads — faster approvals, budget preserved, fewer reworks.
- Web Portal Product Owners — stable ISI/fair-balance patterns, provable consent, clean audits.
- Agencies & Vendors — unambiguous acceptance criteria, checklists, and SLAs.
Proof / Mini-KPIs
↓ time-to-approval
(up to 25%)
↓ rework rate
(~30%)
≥95%
pre-flight pass
≥90%
consent coverage
≥98%
on-time sunsets
What’s delivered
- 1. OPDP/APLB Templates (ready-to-use)
- Claims & Evidence Matrix (MLR-ready)
- ISI & Fair-Balance Patterns (web/email/social/video)
- Copy & Visual Guardrails (MOA, boxed warnings, REMS)
- Channel Boilerplates (SEM, social, email, LP disclosures)
- 2. Pre-flight & QA (≥95% target)
- Channel Checklists (Search, Social, Programmatic/CTV, Web/LP, Email/CRM, PDF/Detailers)
- Evidence Pack (annotated comps, PI version/date, refs)
- Redline Taxonomy (severity, root cause, fix-by; monthly trends)
- 3. Consent & Privacy (HIPAA/GDPR aware)
- CMP Patterns (states, purposes, regional gating, de-ID)
- PV Intake & AE/PC Triage (routes, 24-hour handoff, audit log)
- Data Retention & DSR Flows (timers, opt-out/delete)
- 4. Audit Trail & Governance
- Change Control SOP (tickets, versioning, approvals, sunsetting)
- Vendor SLAs & Scorecards (compliance, timeliness, quality)
- Risk Register (likelihood × impact, owner, mitigation)
- 5. Training & Adoption
- MLR Prep Workshops • Pre-flight Build Clinics • Quick-reference cards
Problems solved
- Endless MLR loops
- Inconsistent ISI/fair balance
- Consent gaps & unclear PV intake
- Fast but off-standard agency work
- No versioning/expiration → stale claims in market
Operating cadence
Weekly
15-min Pre-flight/Decision sync
Monthly
Compliance trend review + allocation check
Quarterly
QBR, vendor scorecards, roadmap
FAQs
Is this only strategy?
No—strategy plus build, activation, and the weekly cadence to keep it performing.
How do you handle compliance?
OPDP/APLB patterns, reviewer packets, consent/PV routes; every claim mapped to evidence.
How does field fit in?
Salesforce/Veeva triggers, NBA rules, and closed-loop signals flow into the Weekly One-Pager.