Scientific, Regulatory & Quality

CMC Strategy & Development

Scientific and regulatory alignment for faster approvals.

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Build smarter CMC plans from the start.

Your Chemistry, Manufacturing, and Controls (CMC) strategy is foundational to your program’s success. At Syner-G, we develop CMC programs that are scientifically rigorous, phase-appropriate, and aligned with regulatory expectations.

 From preclinical through post-approval, we connect strategy to execution—ensuring your plans not only support product design and development goals, but also withstand global scrutiny. Whether you’re starting from scratch or remediating gaps, our experts reduce risk, streamline execution, and keep your program moving forward.

Challenges we can help solve:

Lack of clear, connected development strategy
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Pressure to move fast while avoiding risk
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0%+

Client Return Rate

Assets Supported

INDs Filed

NDAs / BLAs Filed

Trusted across hundreds of global submissions.

CMC strategy and execution across modalities—faster, safer progress.

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Our Approach

Strategy, science, and execution—seamlessly connected.

We don’t just advise—we design and run CMC strategies that keep programs on track. From ground-up planning to targeted fixes, we right‑size support to your goals, timelines, and capacity.

Modalities: small molecules, biologics, cell & gene
Lifecycle: hands‑on from preclinical to launch
Regulatory: aligned with FDA, EMA, and global regulations
Cross‑functional: regulatory, quality, medical writing as one

We can help with: