CMC Risk Diagnostic
A focused assessment of your CMC position that identifies gaps in analytical, manufacturing, and control documentation and ranks the risks most likely to affect upcoming milestones.
Learn More about CMC Risk DiagnosticCMC strategy grounded in science and regulatory experience.
Regulatory CMC guidance for small-molecule, peptide, and oligonucleotide therapeutics, from pre-IND planning through clinical development.
Scientific Development
Connect analytical, formulation, and manufacturing considerations with phase-appropriate regulatory CMC strategy.
Regulatory Review
Identify submission gaps, anticipate review questions, and prioritize issues that could affect development milestones.
Strategic CMC Guidance
Align technical partners, development priorities, and regulatory deliverables through focused CMC leadership.
Three engagements, matched to your development stage.
From a focused CMC risk assessment to IND readiness and ongoing CMC leadership.
IND-Ready CMC System™
Develop a phase-appropriate CMC strategy and submission package aligned with regulatory expectations and your program’s development stage.
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CMC Leadership Retainer
Ongoing regulatory CMC leadership and strategic advice as development priorities, manufacturing partners, and regulatory requirements evolve.
Learn More about CMC Leadership RetainerWhy Nexus
Specialized expertise. Direct collaboration.
Nexus works with emerging biotech and lean pharmaceutical teams to identify CMC risk, coordinate CDMO and laboratory partners, and prepare regulatory documentation appropriate to each stage of development.
Modality focus
Regulatory CMC experience across small-molecule, peptide, and oligonucleotide programs and their distinct analytical and manufacturing considerations.
Review-informed perspective
Experience spanning regulatory review and pharmaceutical development shapes how we anticipate agency questions and weigh CMC risk.
Direct senior engagement
Engagements are led directly by senior CMC expertise and scoped to the milestone in front of you.
Latest insights from Nexus.
Perspectives, video insights and LinkedIn articles from the Nexus team are collected on CMC Perspectives.