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CMC Chemistry Manufacturing Control Services

Development of new pharmaceutical products starts with chemistry, manufacturing and controls (CMC). The CMC chemistry manufacturing control process provides essential steps to scale a drug from laboratory bench studies to clinical trials and beyond. Analytical services provide the basis for pre-formulation and formulation, leading to successful drug product development. Documenting each step along the way ensures that your drug products, substance or formulation will meet regulatory compliance designed to ensure safety and quality. These considerations include formulation, analytical services, and regulatory compliance.

CMC Pharmaceutical Development

Southwest Research Institute provides researchers, startups and drug makers with contract CMC pharmaceutical development services ranging from analytical to regulatory compliance to CGMP manufacturing, drug product development and drug formulation. Our laboratories meet CGMP manufacturing requirements for API and drug product manufacturing.

Visit Pharmaceutical Formulation Development to learn about pre-formulation, formulation, and drug product services. Learn about Pharmaceutical Process Development including chemical process development.

Pharmaceutical Analysis Services

We perform pharmaceutical analysis services in our Pharmaceutical Testing Laboratories and other analytical services in our Chemical Analysis Services facilities.

Regulatory Services

Additional CMC chemistry manufacturing control services can be found at Program Management & Regulatory Submissions. Visit Analytical & Regulated Projects to learn about our services supporting regulatory compliance, including IND enabling studies, clinical trials, API manufacturing, pharmaceutical analysis and chemical analysis.

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