Full lifecycle execution
Four modules covering qualification through continuous optimization
Each module can be commissioned independently or run as a single continuous mandate across your Asian CDMO/CMO network.
Solutions by operating stage
Right-sized governance for the organization you are building now
The intervention flexes with portfolio maturity, internal capacity, and the complexity of your Asian CMO/CDMO network.
Build the operating foundation
Senior execution capacity without building a regional function
Elyzora establishes the essential CMO/CDMO controls around an early portfolio, creating a disciplined operating path from partner selection through transfer, release, and first commercial supply.
- CMO/CDMO search, diligence, and qualification
- Right-sized release, escalation, and evidence routines
- Embedded support through transfer, PPQ, and launch
- Engagement format
- Focused project or embedded launch mandate
- Operating value
- Faster operating readiness with fewer fixed regional resources
Phase
I
Technical Onboarding & CMO/CDMO Interface Readiness
Site pre-audit, commercial due diligence, and E2E corridor engineering.
Technical RFP & Site Pre-Audit
Mapping QTPP/CQA/CPP metrics and evaluating plant engineering, 21 CFR Part 11 / GAMP 5 data integrity, and cleaning limits prior to formal cGMP audits.
Commercial Due Diligence
Benchmarking BOM conversion fees, yield loss terms, and MSAs against live APAC manufacturing index rates.
E2E Corridor Engineering
Validating GDP cold-chain lanes, Incoterms, customs clearance frameworks, and secondary API/KSM sourcing.
Phase
II
Tech Transfer SCM Interface & Alignment
Direct liaison bridging global company tech transfer teams with the CDMO site.
SCM-to-Site Operational Bridging
Serving as the direct supply chain liaison between company Tech Transfer teams across the U.S., UK, and EU and the CDMO site to resolve cross-border operational friction.
Execution Alignment
Coordinating raw material staging, testing release timelines, and PPQ campaign logistics to accelerate technology transfer milestones and minimize process handover gaps.
Phase
III
Strategic Vendor Governance & Fractional SCM Management
Active on-ground oversight, yield auditing, secondary site activation.
Active On-Ground Oversight
Physical batch tracking from local API delivery through formulation, testing, and port dispatch.
Yield Auditing & Secondary Activation
Annual auditing of yield actuals against contractual targets, indexing transfer pricing, and activating secondary sites when volume thresholds are breached.
Phase
IV
Joint Steering & Continuous Optimization
Quarterly governance reviews and COGS reduction roadmaps.
CDMO Scorecards
Standardized performance benchmarks reviewed every quarter with company leadership.
Capacity Allocations
Long-term line planning aligned to company demand and launch sequencing.
COGS Roadmaps
Continuous cost-reduction targets tracked to closure across the vendor base.
Ready to scope a module against your current CDMO footprint?