About Deicell Systems

DeiCell Systems is a regulatory and quality systems consultancy supporting pre-commercial and early-clinical biotech and medtech organizations as regulatory expectations accelerate.We design phase-appropriate GMP and QMS infrastructure that is audit-defensible without overengineering, aligned to stage, manufacturing model, and real regulatory exposure!

To learn more about how we can help:

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Our systems are designed to hold up under inspection while remaining usable by small teams.

Who We Serve

We work with:

1. Early-stage biotech companies

Scaling GMP activities under increasing regulatory scrutiny.

2. Early-stage medtech companies

Navigating quality system expectations without mature in-house leadership.

Typically pre-seed through Series B, these teams need quality infrastructure that exists now, not systems built for a future phase.

Built for Early-Stage Teams

DeiCell Systems is built for organizations where innovation velocity has outpaced internal quality structure.Our work reduces ambiguity, stabilizes execution, and prevents uncontrolled expansion of scope as regulatory pressure increases.

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Core Services

1. Right-Sized GMP / QMS Blueprint
• Phase-appropriate system architecture
• Defined scope boundaries and deferrals
• Practical implementation roadmap2. Gap Repair Sprints
• Targeted system stabilization
• Focused remediation of failing areas
• Clear closeout expectations3. Audit Readiness Sprints
• Readiness assessment and prioritization
• Evidence and documentation alignment
• Inspection preparation and support4. Partner Insert Support
• Bounded specialist workstreams
• Decision-ready outputs
• Defined interfaces and cadence