YOUR STRATEGY PARTNER
Informed Insight. Decisive Action.
At DDX, we operate at the critical intersection of Formulation Science, Drug Product Development, and Delivery-Device Engineering — where complexity becomes strategy
INDUSTRY INSIGHTS
Why Drug–Device Strategy Is Now a Board-Level Priority
From Molecule to Medicine- The Strategic Power of Formulation Decisions
Our Services
CMC Program Stewardship
Provide disciplined CMC leadership that defines critical paths, establishes technical governance, and drives cross-functional alignment across CMC, Research, Clinical, Commercial, Quality, and Regulatory. We translate strategy into executable plans through structured oversight and decision cadence.
Formulation And Delivery Framework
Establish the right formulation paradigm early through strategy that defines high-concentration feasibility, stability and forced-degradation approaches, excipient selection with tolerability considerations, rheology/ injectability strategy for subcutaneous delivery. We integrate sequence- and structure-informed risk assessments, excipient rationale, and delivery-route constraints into a cohesive formulation architecture.
Drug Product Architecture
Establish a robust drug product design that integrates formulation design, rheology and injectability, process development, fill–finish strategy, process characterization, control strategy, PPQ readiness, stability risk, and E&L requirements into a cohesive product blueprint that enables scalable manufacturing and predictable quality.
Device Integration and Combination Product Roadmap
Create a unified combination-product architecture aligning formulation attributes, container–closure systems, delivery device design, human factors, and manufacturing considerations from the outset. We convert complex drug–device interface requirements into clear integration roadmaps that balance performance, patient experience, scalability, and regulatory expectations.
End-to End Product Architecture
Define an end-to-end product architecture from the outset that unifies molecule, formulation, drug product, delivery device, design controls, verification & validation, human factors, process, and manufacturing into a single, integrated development framework—ensuring aligned decisions, reduced risk, and predictable progression to commercialization.
Technical Due Diligence
Enable confident investment and partnering decisions through rigorous evaluation of molecule, product, process, and manufacturing readiness against intended commercial use and value-inflection milestones. We translate complex technical risk into clear, defensible assessments that inform valuation and deal structure.
Risk Assessment and Design Decisions
Drive high-quality product decisions using structured risk and decision frameworks that evaluate key technical choices across multiple domains. We convert uncertainty into actionable recommendations that define tradeoffs, prioritize mitigation, and guide execution.
Regulatory and Submission Support (Module 3)
Strengthen regulatory readiness through cohesive Module 3 content strategy, integrated CMC narratives, and structured readiness and risk reviews. We translate complex development data into clear, regulator-ready documentation and defensible technical positions.