Launch Stage

Commercialize at Scale

Scale commercial operations with confidence. Track HCP compliance, prevent

promotional violations, and maintain manufacturing quality at commercial scale.

The Launch Compliance Challenge

The Launch
Compliance Challenge

Multi-jurisdictional conflicts, AI documentation gaps, manufacturing readiness issues

Multi-jurisdictional conflicts, AI documentation

gaps, manufacturing readiness issues

Commercial launch requires managing complex compliance requirements across sales, marketing, and manufacturing.

HCP interactions must be tracked for Sunshine Act compliance, promotional materials need constant monitoring,

and manufacturing scale-up introduces new quality challenges. Traditional point solutions create silos and compliance

gaps that can result in violations, fines, and market delays.

Commercial launch requires managing complex compliance

requirements across sales, marketing, and manufacturing. HCP

interactions must be tracked for Sunshine Act compliance,

promotional materials need constant monitoring, and manufacturing

scale-up introduces new quality challenges. Traditional point

solutions create silos and compliance gaps that can result

in violations, fines, and market delays.

TFives Launch Solutions

One Platform, Five Stages,
Complete Compliance

CommercialCore

HCP & promotional compliance ensures complete

transparency and regulatory adherence across all

commercial activities

✓ HCP interaction tracking

✓ Promotional material review

✓ Sunshine Act compliance

MediusIQ

Launch evidence generation accelerates market insights

and supports commercial success with real-world data.

✓ Real-world evidence collection

✓ Launch analytics

✓ Market intelligence

MediusIQ

Launch evidence generation accelerates market insights

and supports commercial success with real-world data.

✓ Real-world evidence collection

✓ Launch analytics

✓ Market intelligence

RegIQ

Commercial-scale GMP ensures manufacturing quality

and compliance as you scale production to meet market

demand.

✓ Scale-up validation

✓ Commercial GMP compliance

✓ Quality system management

AskRexi

Post-approval change guidance ensures regulatory

compliance as you adapt manufacturing and processes

post-launch.

✓ Change management guidance

✓ Regulatory impact assessment

✓ Submission requirements

Key Outcomes

One Platform, Five Stages,
Complete Compliance

Minimal Commercial

Violations

Comprehensive compliance

monitoring prevents violations and

ensures regulatory adherence

Full Sunshine

Act Compliance

Automated HCP tracking ensures

complete transparency and

regulatory compliance

Launch Evidence

in Weeks

Integrated evidence generation

accelerates market insights and

commercial success

Continue Your Compliance Journey

← Approval Stage

Lifecycle+ Stage →