Kinexum Services

Parent

Kinexum is a strategic advisory firm providing guidance on regulatory, clinical, CMC and other translational aspects of life science product development. Founder Zan Fleming is a bit of a regulatory 'rock star', having led the reviews at FDA that resulted in approval of the first statin, human insulin analog, PPAR agonist and growth hormone for non-GH deficiency conditions, as well as metformin. We've since expanded our therapeutic areas from diabetes, metabolic, endocrine, and CV to GI, oncology, neurology and some ophthalmology, and modalities from small and large molecules to advanced therapies, medical devices, nutritionals and others. You can see from our consultant bios that most have decades of experience at FDA, in industry or in academia. We like to become involved in tricky negotiations with or submissions to FDA. Kinexum is also involved in the metabesity movement for extension of healthy life span, see www.metabesity2020.com.

Regulatory, clinical, CMC, FDA, metabesity

https://www.kinexum.com

Harpers Ferry, WV
United States