Glycobiology · Rare Disease · Regulatory Science · Fractional CSO
Your Scientific Navigator from Discovery to IND
25+ years at the intersection of glycobiology, M6P pathway biology, and rare disease drug development — guiding programs to their True North milestone.
Portfolio & Programs
Strategic Impact
Lysosomal Target Program A
Lysosomal Target Program B
Metabolic Program C
Organizational Relationships
Trusted by Leading Institutions
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The Virtual C-Suite
A Complete Service — Without the Overhead
Glyko brings together a network of specialized professionals who work as a coordinated team on your program, giving you C-suite caliber coverage at a fraction of the cost.
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Toxicology Expert
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CMC Strategy Specialist
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Bioanalytics Lead
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Regulatory Affairs
What We Do
Three Lanes of Expertise
Vertical 01
Scientific Strategy
From assay development to IND-enabling study oversight, we build the scientific foundation your program needs to move forward with confidence.
- Assay development & optimization
- Nonclinical program design
- IND-enabling study oversight
- Scientific due diligence
- M6P pathway expertise
Vertical 02
Executive Stewardship
Whether you need a fractional CSO or a scientific voice in the boardroom, we bring senior-level guidance without the overhead of a full-time hire.
- Fractional CSO services
- Board advisory roles
- Investor preparation
- Scientific narrative for grants
- Partner and CRO selection
Vertical 03
Regulatory Navigation
We map the regulatory path from early strategy through Pre-IND meetings, Orphan Drug Designation, and FDA submission preparation.
- Pre-IND meeting strategy
- Orphan Drug Designation
- NHP waiver development
- FDA meeting preparation
- Early Phase regulatory plan
The Glyko Brief
Regulatory Intelligence & Perspective
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Not sure which solution fits your program? Let's navigate together.
