Chemistry, Manufacturing, and Controls (CMC)

CMC in Drug Development and Life Cycle Management

Establish a strategy that meets regulatory requirements from agencies like the FDA and EMA, and other regulatory agencies.
Regulatory submission: Compiling the necessary data on the drug’s quality, manufacturing process, stability, and analytical methods.
cGMP clinical and commercial manufacturing and process design: Optimizing and validating the processes for producing the drug product, from early-stage development to commercial scale-up.
Quality assurance and compliance: Ensuring that all practices meet Good Manufacturing Practice (GMP) and other compliance standards.
Conduct cGMP/GLP/CGP audits in compliance with FDA and EMA and other agencies.
Process optimization in Upstream and Downstream, DoE design, Process Performance Qualification, and Risk Assessment.
Clinical and commercial cGMP manufacturing, manufacturing batch records and trouble shooting.
cGMP facility design with flexible and modular in compliance with US FDA and EU GMP standards.

Promising clinical results and accelerated clinical studies allow less time for product development

The BLA itself is typically organized into different modules, following the structure of the Common Technical Document (CTD)

Module 1: Administrative Information and Prescribing Information
Module 2: Summaries (including the Quality Overall Summary, Nonclinical Overview, and Clinical Overview)
Module 3: Quality (CMC information)
Module 4: Nonclinical Study Reports
Module 5: Clinical Study Reports

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