Set your program up for clinical and market readiness.
CMC is the cornerstone of successful drug development. It’s vital for maintaining quality, satisfying regulatory requirements, and enabling reliable large-scale manufacturing.
At Syner-G, our experts are here to help you navigate the entire journey, from developing initial formulations and manufacturing procedures to ensuring consistent, high-quality production for widespread clinical use. We partner with you to set the stage for seamless regulatory approval and successful commercialization.
With deep expertise in CMC, regulatory strategy, compliance, quality systems, and process automation, our team provides the strategic guidance and operational support you need to scale and succeed. Whether you’re preparing for NDA, BLA, or MAA submissions, we help accelerate your path to approval, ensuring your therapies are safe, effective, and market-ready.
Challenges we can help solve:
Lack of development strategy
We embed experienced engineers, operators, and project leads who deliver hands-on execution—filling critical capability gaps and accelerating your path to operational scale.
Pressure to optimize CMC and quality strategies post-approval
We help organizations optimize control strategies, quality systems, and CMC documentation to support tech transfers, manufacturing changes, and global supply continuity.
Lack of suppliers or vendors
Our integrated model spans engineering, systems, tech transfer, and GMP operations—giving you a single point of accountability for technical execution. With an operator’s perspective, we help design systems and processes that perform from day one.
Lack of internal resources to scale infrastructure and operations
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.
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.
Client Engagements
Subject Matter Experts
Client Return Rate
Streamline your path-to-market approval.
A track record of success.
With hundreds of submissions supported across global regulatory pathways, we’ve helped bring a wide range of therapies—spanning diverse modalities and therapeutic areas—to markets across the world.
Integrated, end-to-end support.
Our proprietary CMC 360° approach connects product development, engineering, and regulatory foresight—so your asset is built for both approval and long-term scalability.
Our Solutions
Science + Strategy + Delivery
Scientific, Regulatory & Quality
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Strategy & Transformation Consulting
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Technical Operations & Delivery Infrastructure
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Let's move from science to success.
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