Solutions

Scientific, Regulatory & Quality

Expert guidance from discovery to approval—and beyond.

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Solutions

Scientific, Regulatory & Quality

Expert guidance from discovery to approval—and beyond.

Let’s Talk

Solutions

Your strategic development & delivery partner.

Creating value at every stage of product development and delivery.

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You’re in the right place!

Sequoia BioTech Consulting has officially rebranded to Syner-G

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New name, expanded capabilities, one unified partner.

Sequoia BioTech Consulting has joined Syner-G BioPharma Group—uniting two trusted teams into one stronger partner with the scale and expertise to guide programs from early development through commercialization. Under the Syner-G name, we’re more than the sum: a Strategic Development & Delivery Partner built to navigate complexity, reduce risk, and accelerate your path to market.

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The expertise to move your program forward.

At Syner-G, we help biopharma companies navigate the high-stakes journey from early development through post-approval with clarity, speed, and scientific rigor.

As a strategic development and delivery partner, we bring deep expertise across discovery, CMC, regulatory, medical writing, and quality systems—guiding your program from preclinical stages to global submissions and lifecycle management. Our integrated approach reduces risk, aligns teams, and ensures that every step you take moves you closer to approval and market impact.

Challenges we can help solve:

Limited internal expertise to guide early decisions
Our integrated teams guide your earliest decisions with cross-functional expertise that aligns science, quality, and long-term objectives.
Lack of a coherent, forward-looking development plan
We design and execute forward-looking, risk-managed programs that reduce downstream issues—and speed your asset through development and approval.
Delays or missteps that could derail timelines or funding
Our integrated model helps clients avoid regulatory setbacks, quality gaps, and disconnected development plans that could delay key milestones—or jeopardize investor confidence.
Fragmented planning across functional silos
We bring together experts in discovery, CMC, regulatory affairs, quality, and medical writing, to guide your program forward as a cohesive whole—ensuring smooth handoffs and aligned priorities throughout development.
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.
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.
Increased complexity in global lifecycle management
We provide strategic and operational support for global variations, line extensions, and post-approval changes—helping clients maintain product quality, meet evolving regulatory expectations, and keep therapies accessible to patients worldwide.
Growing volume and complexity of regulatory submissions
Our teams support authoring, QC, formatting, and coordination for large-scale regulatory submissions, from routine updates to major global filings—ensuring consistency, efficiency, and regulatory compliance across functions and geographies.
Pressure to optimize CMC and quality strategies post-approval
We help organizations reassess and optimize control strategies, quality systems, and CMC documentation to support tech transfers, manufacturing changes, and global supply continuity.
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.

Trusted by emerging biopharma 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

0%+

Client Return Rate

Assets Supported

INDs Filed

NDAs / BLAs Filed

Scientific, Regulatory & Quality

De-risk and accelerate your path to approval.
With deep scientific, regulatory, and quality expertise, we guide therapies through the stages of drug development from preclinical to commercialization. Our solutions are built to minimize risk, streamline progress, and extend product value.

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Strategy & Transformation Consulting

Navigate complex change. Improve performance. Scale with confidence.
We bring top-tier consulting experience and deep life sciences expertise to drive strategic initiatives across M&A integration, AI and digital transformation, and organizational design.

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Technical Operations & Delivery Infrastructure

Scale efficiently and operate with confidence.
We provide technical expertise, operational leadership, and hands-on support to turn strategy into scalable, compliant execution. Embedded alongside client teams, we lead and manage the technical operations and infrastructure that drive performance and deliver on business goals.

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Scientific, Regulatory & Quality

De-risk and accelerate your path to approval.
With deep scientific, regulatory, and quality expertise, we guide therapies through the stages of drug development—from preclinical to commercialization. Our solutions are built to minimize risk, streamline progress, and extend product value.

Learn More

Strategy & Transformation Consulting

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Technical Operations & Delivery Infrastructure

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Overall, Syner-G has been able to prove not only that they have the expertise and industry experience but also that they are agile in their knowledge and are ultimately sophisticated problem solvers.

Chief Operating Officer

International Biotechnology Company

The partnership with Syner-G fulfilled Yumanity’s CMC needs in an effective and efficient manner. The Syner-G team was easy to work with and in this business, that really matters.

Paulash Mohsen

CBO and head of CMC and Program Management

Syner-G took ownership of the project as if it belonged to them, making themselves available 24/7 for real-time manufacturing concerns and engaging closely with the FDA on our behalf to satisfy regulatory and quality requirements.

SVP

International Biotechnology Company

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A complete, fully-integrated solution.

Our integrated approach connects CMC, regulatory, quality, and medical writing from early development through approval—reducing handoffs, aligning teams, and helping you avoid costly delays.

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