Chemistry, Manufacturing, and Controls (CMC)/ Pharmaceutical Science

Chemistry, Manufacturing, and Controls (CMC) is a critical aspect of the life science industry, CMC encompasses a broad range of activities that ensure the quality, safety, and efficacy of these products throughout their lifecycle, from initial development to commercialization.

Kymanox’s expert staff of pharmaceutical development scientists and drug delivery device engineers can provide a breadth of strategic development and regulatory planning services throughout the stages of clinical development and up to market authorization. Kymanox is well versed in navigating the complexities of product development to deliver and maximize the potential for commercial success:

  • Diverse team with expertise in CMC and drug development
  • Commitment to quality, safety, and regulatory compliance
  • Tailored solutions to meet unique client needs
  • Proven track record of successful drug development projects
  • Dedicated support throughout the drug development lifecycle
  • CMC Capabilities

    These services include, but are not limited to, the evaluation of formulation technologies and selection and optimization of drug product formulation; evaluation of manufacturing process technologies, process development, scale-up, and technology transfer.
    01

    Pharmaceutical Science

    We guide clients through every stage of the drug development process, from target identification to post-marketing surveillance. Our experienced team assists in target identification and lead optimization, conducts preclinical research to assess safety and efficacy, and prepares high-quality Investigational New Drug (IND) applications for regulatory submission.
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    02

    IND

    Kymanox has an expert staff of regulatory and technical writers who are intimately familiar with authoring the CMC (Quality) sections for all submission types. Kymanox is also well versed in preparing all sections of your submission, as well as Briefing Packages to support communications from Pre-IND through Pre-NDA/BLA.
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    03

    Process Optimization

    Support to optimize your manufacturing processes for efficiency, scalability, and cost-effectiveness while maintaining product quality.
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    04

    Technology Transfer

    Moving a product from development to commercial-scale manufacturing often involves transferring technology between different facilities or partners. We ensure a smooth transition, minimizing risks, and maintaining product integrity throughout the transfer process.
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    Frequently Asked Questions (FAQs)

    Can Kymanox author CMC (Quality) Sections of my IND, NDA, ANDA, or BLA?
    Kymanox has an expert staff of regulatory and technical writers who are intimately familiar with authoring the CMC (Quality) sections for all submission types.  Kymanox is also well versed in preparing all sections of your submission, as well as Briefing Packages to support communications from Pre-IND through Pre-NDA/BLA. 
    What other documents can Kymanox author?
    The comprehensive CMC support offered by Kymanox includes, but is not limited to, Quality by Design (QbD)  documentation including CQAs and CPPs, Target Product Profile (TPP), and Quality TPP (QTPP), as well as Common Technical Document (CTD) Module 3 (i.e., 3.2S and 3.2P) authoring for submission of global investigational products and market authorization. 
    Can Kymanox help with the selection and setup of my laboratory instrumentation and equipment?
    Absolutely! The Kymanox Analytical Sciences group has professionals with global experience working with a vast array of laboratory instrumentation and equipment from bench-scale to commercial-scale in the pharmaceutical, biotechnology, medical device, and in vitro diagnostic industries. We provide on-going support for all phases of development, from discovery to post-commercialization, with services ranging from research and selection of instrumentation/equipment that are best suited to your project needs, setup and qualification of instrumentation/equipment intended for GxP use, as well as troubleshooting issues with system performance and/or assay optimization.

    Voice of the Customer

    "The team was responsive, adaptable, very communicative, and willing to do whatever we asked."
    WILLIAM BOHNAKER
    DIRECTOR OF OPERATIONAL EXCELLENCE AT A RAPIDLY GROWING BIOPHARMACEUTICAL COMPANY
    "They make it make sense"
    VICE PRESIDENT, GLOBAL REGULATORY AFFAIRS