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Spark CMC Consulting Corp.
that provides Regulatory CMC services for the pharmaceutical and biopharmaceutical industries.
Build strategies, build confidence, build your business.
Regulatory CMC Strategy and Intelligence
We provide strategic advice and planning of regulatory CMC submissions at both pre- and post- marketing phases based on global regulatory requirements.
CMC Regulatory Gap Analysis
We conduct procedural and submissions reviews to identify gaps and inconsistencies. We perform assessments in light with global regulatory requirements, so sponsors can feel confident about their submissions.
Conformance and Compliance
We work with manufacturers and sponsors to fulfill any CMC-specific commitments made with the Health Authorities and help establish CMC conformance as a key element to maintain CMC compliance.
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Spark CMC is always with you
Founded in 2019, Spark CMC takes pride in supporting companies of all shapes and sizes at the clinical and post-marketed phases with targeted services.
Authoring Services, CMC Portfolio Management, Compliance, and Training
Spark CMC Case Study
View our case studies to learn more about what we do.
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