FDA special designations

Kinexum provides regulatory consulting services for life science products, using experience with major agencies worldwide such as FDA, EMA, and MHRA to help clients with regulatory, nonclinical, CMC, and related development and commercialization challenges. Since 2003, Kinexum has supported over 500 companies globally with a team of more than sixty subject matter experts, most holding MDs, PhDs, MBAs, or JDs, based across North America, Europe, and Asia.

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CDMO selection and managementclinical supply planning and managementCMC consultingdue diligencegap analysisnonclinical study design and monitoringquality assurance and controlregulatory strategy and pathway analysisregulatory submissions (IND, NDA, BLA, IDE, 510(k), de novo, PMA)