The good thing about having Elexes at your side while developing biologics or drugs is that we have the expertise at all stages of drug development. Whether you are at the initial development stage or post-approval stage, we can offer you the best support in building and executing a CMC strategy customized to your drug’s unique composition, use, and formulation process.
Having robust Chemistry and Manufacturing Controls (CMC) is one of the essential things not just on the regulatory compliance front, but also for the safety of patients. At Elexes, we understand this and have experts who will assist you in understanding all the CMC requirements and help you design and implement risk-based, phase-appropriate CMC solutions for your Biologics or Drug.
We have a dedicated team of experts who have years of experience in CMC consulting.
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