Client Challenges We Solve
Why Companies Call Us
If any of these sound familiar, this engagement is built for you.
Temperature excursions undetected until product is compromised
GDP/HIPAA compliance gaps in distribution
Clinical trial drug supply chain integrity (randomization, blinding, returns)
Serialization and track-and-trace requirements
Vendor qualification program inadequate
Audit readiness (FDA, EMA, DEA) not maintained continuously
Our Approach
A 4-Phase Engagement
Structured, transparent, and built around measurable outcomes.
Cold Chain Risk Assessment
End-to-end temperature mapping. Identify excursion risks by lane, mode, and season. Qualify packaging and monitoring.
Compliance Program
GDP gap analysis, SOP redesign, vendor qualification, deviation management. HIPAA/HITECH for clinical data.
Validation & Qualification
Packaging qualification (ISTA), lane validation, monitoring system validation (GAMP 5).
Audit Readiness
Mock audits, CAPA program, training, document control. Sustained audit-readiness program.
Engagement Deliverables
- Cold chain risk assessment and temperature map
- GDP/HIPAA gap analysis and remediation plan
- SOP library and quality manual
- Vendor qualification program
- Packaging and lane validation reports
- Mock audit report and CAPA tracker
- Serialization and track-and-trace strategy
What Clients Typically See
Recent Engagement
Mid-size biotech sponsor (Phase III trial)
Zero excursions across 4,200 shipments, FDA audit passed
Redesigned clinical supply chain, validated packaging, GDP SOPs. Saved $8M in avoided trial delays.
Industries
Where This Applies
Cross-industry expertise with operator credibility in each.
Start with a 45-Minute Discovery Call
Tell us about your situation. A senior advisor will respond within 1 business day with a personalized engagement proposal.
Start with a 45-Minute Discovery Call
Senior advisor, no slide deck, no pressure. Just a working conversation about your supply chain and what would move the needle.