Chemistry, Manufacturing & Controls (CMC)

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A robust CMC strategy is essential for successful development, regulatory approval, and commercial manufacturing. GSAP helps organizations establish scalable manufacturing processes, reliable analytical methods, and effective control strategies that support product quality throughout the entire lifecycle.

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Our services include:

  • Process Development & Scale-Up
    Strategic guidance on drug substance (DS) and drug product (DP) process design, parameter optimization, critical process parameter (CPP) mapping, and scalable manufacturing workflows—spanning synthetic small molecules, recombinant proteins/mAbs, and complex ATMPs (cell and gene therapies, tissue-engineered products, genome-edited products, RNA modalities, and personalized (n-of-1) therapies).
  • Translation to GMP & Tech Transfer
    Seamlessly bridging the gap from bench-scale research to phase-appropriate Good Manufacturing Practice (GMP) environments—including facility fit assessments, cleanroom strategies, vendor/CDMO selection and oversight, and raw material/excipient qualification.
  • Analytical Method Development & Characterization
    Guidance on the selection, qualification, and validation of robust analytical assays for release testing, stability profiling, and critical quality attribute (CQA) determination— including physicochemical and chromatographic profiling, biological potency assays, VCN, identity, purity, and safety testing (sterility, adventitious agents).
  • Comparability & Module 3 Compilation
    Structuring comprehensive CTD Module 3 and IMPD/IND CMC sections with dedicated comparability protocols to manage site transfers, scale-up, and process modifications throughout early and late-stage clinical development.