Scientific, Regulatory & Quality
CMC Strategy & Development
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 help clients develop CMC programs that are scientifically rigorous, phase-appropriate, and aligned with regulatory expectations.
From preclinical through post-approval, we connect strategy with execution—ensuring your plans not only support your product design and development goals, but also hold up to global scrutiny. Whether you’re starting from scratch or remediating gaps, our experts help reduce risk, streamline execution, and keep your program moving forward.
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.
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.
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.
Client Return Rate
Assets Supported
INDs Filed
NDAs / BLAs Filed
Trusted partner with hundreds of INDs filed.
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 our support to match your goals, timelines and capacity.
- Modalities: small molecules, biologics, cell & gene
- Lifecycle: hands‑on from preclinical to launch
- Regulatory: seasoned and experienced with deep understanding of global regulations and expectations
- Cross‑functional: technical, regulatory, quality, medical writing—all as one
We can help with:
CMC Strategy Development and Regulatory Alignment
Analytical Method Development and Validation Oversight
CDMO Selection, Tech Transfer, and External Oversight
Specification Setting, Justification, and Control Strategy Design
Post-approval Lifecycle Support and Gap Remediation
Crisis Stabilization Services
Dual Diagnosis Programs (Mental Health + SUD)
Product Development and Regulatory Alignment
Impurity Risk Assessments and Comparability Protocols
Technical Writing (With or without source documents from your CDMOs)
CMC Module Content for IND, IMPD, NDA, BLA, MAA Submissions
A complete, fully-integrated solution.
Discovery Sciences
Regulatory Strategy
Medical Writing
Quality & Compliance
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Let's move from science to success.
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