How We're Structured

Two service lines. One partner. Full accountability.

CellServe's services are organized into two complementary service lines, each with a clearly defined scope and governance model. The service lines can be engaged independently or together depending on the needs of your program. This structure ensures regulatory clarity while allowing programs to scale support as they grow.

Service Line 1

Cellular Therapy Consulting

Service Line 2

Clinical Trial Support

Service Line 1

Cellular Therapy Consulting

Institutional readiness, system design, and sustainable program development for advanced cellular therapy delivery. This is CellServe's advisory function, supporting institutions, sponsors, and manufacturers as they design, evaluate, and strengthen cellular therapy programs.

Site assessment & qualification
Quality system design, optimization & regulatory readiness
Apheresis logistics, chain-of-identity & chain-of-custody frameworks
Manufacturing operations advisory (process & scale-up)
Regulatory strategy & IND/BLA advisory
End-to-end vein-to-vein operational reliability
FACT accreditation strategy & preparation

Service Line 2

Clinical Trial Support

Strategic and operational alignment for sponsors and innovators advancing cell therapy trials. CellServe serves as the operational lead coordinating sites, CRO partners, logistics providers, and regulatory activities within a unified framework.

Institutional feasibility & sponsor-aligned site selection
Specialized CGT operational expertise integrated alongside CRO execution
Vendor and CRO selection, contracting alignment & oversight frameworks
Cold chain & chain-of-custody management
Regulatory strategy & authority interaction (FDA / ANVISA)
Site close-out & regulatory submission support

Quality systems and consulting in cellular therapy

Service Line 1 Deep Dive

Cellular Therapy Consulting

Strategic advisory for every stage of cellular therapy development.

Service Line 1 provides specialized expertise across the operational and regulatory landscape of cellular therapy. Our team supports strategic planning, document review, regulatory preparation, and program readiness assessments helping organizations build strong foundations before programs launch or expand.

CellServe operates as an external advisor and operational partner, available for structured engagements, targeted projects, and ongoing consultation.

Service Line 2 Deep Dive

Clinical Trial Support & Execution Oversight

End-to-end operational management of your cellular therapy trials.

In Service Line 2, CellServe serves as the operational lead for clinical trials coordinating sites, CRO partners, logistics providers, and regulatory activities within a unified framework.

A Single Operational Lead

Most sponsors must coordinate multiple partners CROs, logistics vendors, regulatory consultants, and manufacturing liaisons. CellServe simplifies this structure by serving as the operational lead for the trial. We coordinate subcontracted CRO partners when needed, maintain quality oversight, and ensure the program operates as a cohesive system.

You gain one accountable partner who understands how every component of cellular therapy delivery connects.

Clinical team coordinating cellular therapy trial execution

One Partner. Two Service Lines.

Scoped independently. Engaged together when it matters.

At-a-Glance Comparison

Which service line fits your need?

A quick reference for choosing between Service Line 1, Service Line 2, or both engaged together.

Dimension

Service Line 1

Cellular Therapy Consulting

Service Line 2

Clinical Trial Support

Best for

Hospitals & clinical sites building programs

Sponsors & manufacturers running CGT trials

CellServe's role

External advisor & system designer

Operational lead across CRO, logistics & sites

Engagement shape

Scoped projects & ongoing consultation

Continuous oversight through trial lifecycle

Primary output

SOPs, governance, FACT readiness

Activated sites, unified coordination, regulatory alignment

Quality oversight

Quality systems designed for daily operation

Embedded quality across every trial partner

Both service lines are scoped, priced, and governed separately ensuring regulatory clarity and no conflicts of interest when engaged together.

How an Engagement Unfolds

From first conversation to operational rhythm.

Whether you engage one service line or both, every CellServe engagement follows the same disciplined arc.

01
Discovery
Scoping call, NDA, and a structured intake of your program goals and gaps.
Week 1
02
Assessment
On-site or virtual readiness review against CGT-specific benchmarks.
Weeks 2–4
03
Roadmap
Prioritized findings, governance model, and a phased implementation plan.
Week 5
04
Execution
Embedded delivery of SOPs, oversight, and continuous inspection readiness.
Ongoing