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Dr Mukesh Kumar

Gaithersburg, Maryland, United States

Ownership: Private
Development stage: Other

Overview

MK Science & Regulation is a science-led regulatory intelligence and strategic consulting firm founded and led by Dr. Mukesh Kumar. The organization specializes in guiding pharmaceutical, biotechnology, and medical device companies through complex FDA and global regulatory pathways. MK Science & Regulation provides comprehensive services in regulatory strategy design, gap analysis, IND/IDE-enabling planning, and clinical trial development. Through its deep expertise in regenerative medicine and advanced therapies, the firm helps innovators accelerate product development and secure regulatory approvals with scientific integrity and compliance.

Therapeutic areas: RheumatologyPsychiatryGastroenterology
Modalities: Cell therapyBiologicSmall moleculeDevice
Industry: Biotech

Partnerships

Akan BiosciencesFDAMap

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