CMC (Chemistry, Manufacturing & Controls)
Chemistry, Manufacturing, and Controls (CMC) form the backbone of translating early-stage drug candidates into safe, scalable, and regulatory-compliant products. At Keysight Chemtech, our CMC services are designed to bridge the gap between discovery and commercialization, ensuring robust processes, validated analytical methods, and reliable manufacturing strategies at every stage of development.
Our multidisciplinary teams of chemists, process engineers, and regulatory specialists collaborate closely with pharmaceutical and biotechnology partners to develop efficient, scalable, and compliant manufacturing workflows. By integrating synthetic chemistry, process optimization, analytical science, and regulatory insight, we ensure that every step from laboratory-scale process design to technology transfer for commercial manufacturing to meets global quality and regulatory standards.
Leveraging modern analytical instrumentation, validated methodologies, and rigorous scientific oversight, we help organizations maintain product consistency, safety, and quality throughout the entire development lifecycle. Our CMC services are tailored to:
- Optimize chemical processes for efficiency, yield, and reproducibility
- Develop and validate analytical methods aligned with regulatory expectations
- Scale laboratory processes to pilot and commercial manufacturing safely
- Ensure regulatory compliance and thorough documentation for global submissions
With Keysight Chemtech as a partner, drug developers can confidently advance candidates from discovery to market, knowing that their processes, analytical strategies, and manufacturing operations are scientifically robust, compliant, and ready for scale-up.
Key Services
Process Development & Optimization
We design and optimize chemical processes to achieve maximum efficiency, reproducibility, and cost-effectiveness. Our team evaluates reaction conditions, raw materials, catalysts, and process parameters to develop robust synthetic pathways. The goal is to minimize waste, improve yield, and ensure the process is scalable and commercially viable, while maintaining safety and regulatory compliance.
Route Scouting & Scale-Up
Our chemists identify and develop the most efficient and safe synthetic routes for active pharmaceutical ingredients (APIs) and intermediates. We evaluate multiple synthetic options to determine the optimum pathway for scalability, yield, and environmental compliance. Scale-up from laboratory to pilot and commercial production is carefully managed to ensure consistent quality, reproducibility, and process safety.
Analytical Method Development & Validation
We develop and validate analytical methods using state-of-the-art instrumentation, including HPLC, GC, LC-MS, and spectroscopy. Our methods are designed to be accurate, precise, reproducible, and fully compliant with ICH, USP, and other global regulatory standards. Validated methods support in-process monitoring, quality control, and regulatory submission requirements.
Impurity Profiling
Understanding and controlling impurities is critical for product safety and regulatory approval. We perform comprehensive identification, quantification, and monitoring of impurities, including degradation products, residual solvents, and trace metals. Our impurity profiling ensures that your compounds meet stringent safety and quality standards at every stage of development.
Stability Studies
We conduct both environmental and long-term stability assessments to determine product shelf life, storage conditions, and packaging requirements. Stability studies help anticipate chemical, physical, and microbiological changes over time, ensuring your products maintain efficacy, safety, and quality throughout their lifecycle. Data generated supports regulatory filings and product lifecycle management.
Clinical Trial Material Supply & Technology Transfer
Keysight Chemtech facilitates the seamless transfer of processes and analytical methods from laboratory development to pilot and commercial-scale manufacturing. We ensure that clinical trial materials are produced with consistent quality, purity, and regulatory compliance. Our technology transfer services minimize risk during scale-up and help clients accelerate timelines for early-phase clinical studies.
Regulatory Compliance & Risk Assessment
Every process, analytical method, and scale-up strategy is designed with regulatory compliance and risk mitigation in mind. Our teams ensure alignment with global standards, including ICH, FDA, EMA, and WHO guidelines. Comprehensive documentation, audit readiness, and risk assessment strategies help clients meet regulatory expectations confidently and reduce development risks.