Product Modality

Cell & Gene Therapy

Specialized consulting solutions, supporting your journey from initial discovery to full commercialization.

Ensure success for your program.

We partner with clients across a broad range of cell and gene therapy types:

Autologous and Allogeneic Cell Therapies
Viral and Non-Viral Gene Delivery Systems
Cell Types: T-cells, NK cells, iPSCs, MSCs, APCs, hESCs, Stem Cells from Blood & Bone Marrow, and more

Our comprehensive services encompass process development, analytical testing, cGMP manufacturing, technology transfer, and regulatory support—all tailored to your program’s unique needs.

Challenges we can help solve:

Limited technical talent
Our integrated teams guide your earliest decisions with cross-functional expertise that aligns science, quality, and long-term objectives.
Unclear development plan
We design and execute forward-looking, risk-managed programs that reduce downstream issues—and speed your asset through development and approval.
Complex, time-sensitive submission demands
Our experienced scientists craft clear, compliant regulatory documents that meet global standards and support every step of the submission process. From authoring and editing to formatting, QC, and coordination, we help clients meet tight timelines for INDs, NDAs, MAAs, and agency briefings—without compromising quality.
Regulatory uncertainty and evolving expectations
We help you interpret and apply global regulatory requirements through a fit-for-purpose, risk-based approach grounded in scientific and operational insight. Whether you’re pursuing an IND, NDA, BLA, or global filings, our experts guide you through every step with clarity and precision.
Pressure to scale quickly
We accelerate execution across engineering, validation, and operations—helping you avoid multimillion dollar delays and hit your launch window.
Inconsistent documentation or quality gaps
Our cross-functional experts identify and remediate documentation gaps, harmonize submission standards, and support audit readiness—ensuring your programs meet evolving regulatory expectations even post-launch.
Missed milestones
Our integrated model helps clients avoid regulatory setbacks, quality gaps, and disconnected development plans that could delay key milestones—or jeopardize investor confidence.

Assets Supported

INDs Filed

0%+

Client Repeat Rate

Move forward with confidence.

Our experts bring decades of experience across the product lifecycle, embedding industry best practices and proven strategies directly into your programs.

Talk to an Expert

Trusted by thousands of innovators.

Our client-first approach ensures that your science stays on track, your documentation holds up to agency scrutiny, and your team gets the support it needs to scale.

Why Choose Syner-G

Independent expertise.

We act as your advocate in CDMO/vendor relationships.

Proven playbooks.

Our methodologies shorten timelines and reduce program risk.

Embedded partnership.

We integrate into your teams to strengthen capabilities that last beyond the engagement.

End-to-end support.

From process design to commercialization, we provide continuity and consistency across the lifecycle.

Our Solutions

Science + Strategy + Delivery

As a strategic development and delivery partner, Syner-G offers integrated support across every phase of the development lifecycle. Whether you’re advancing a new therapeutic through early-stage studies or scaling for commercialization, our three core solution areas work in concert to move your program forward—with clarity, efficiency, and confidence.