Chemistry, Manufacturing, & Controls

At Kymanox, our science-centric Chemistry, Manufacturing, & Controls (CMC) team has global experience in strategic planning and authoring regulatory submissions (e.g., US FDA, EU EMA) for the pharmaceutical, biologic, and combination product (e.g., drug and device) industries. Our multi-disciplinary approach combines expert product and process knowledge with a quality-first mindset to ensure Right First Time submissions.