Kinexum
↗Harpers Ferry, USA
Kinexum is a strategic advisory firm that provides comprehensive guidance for the development of healthcare products, including pharmaceuticals, biologics, medical devices, and digital health solutions. Founded by former FDA medical officers and industry veterans, the firm specializes in navigating complex regulatory pathways and optimizing clinical development strategies.
The company offers end-to-end support from pre-clinical stages through commercialization, with specific expertise in regulatory filings, CMC (Chemistry, Manufacturing, and Controls), and quality compliance. Kinexum is particularly well-regarded for its deep knowledge in metabolic diseases, diabetes, and cardiovascular health, often acting as a strategic extension of its clients' internal teams.
CLASSIFICATION
Company Type:CRO
Therapeutic Areas:
Industry:Pharmaceuticals
Sub-Industry:Regulatory & Clinical Strategic Advisory
SIZE & FINANCIALS
Employees:51-200
Revenue:$10M-$25M
Founded:2003
Ownership:private
Status:operating
FUNDING
Stage:Angel
Total Raised:$0.15M
Investors:Individual Angel Investors
PIPELINE
Stage:Commercial
Lead Drug Stage:N/A (Service Provider)
Modalities:Small molecule, Biologics, Cell therapy, Gene therapy, Medical Devices, Digital Health, Nutraceuticals
Active Trials:0
Trial Phases:-
FDA Approvals:0
EMA Approvals:0
CORPORATE STRUCTURE
Subsidiaries:Kinexum Services LLC, Kinexum Europe
Key Partnerships:PolTREG (Strategic advisory for US TREG therapy registration), 180 Life Sciences (Regulatory support for MHRA and FDA filings), Biocon (Strategic advisory and committee participation), Antion Biosciences (Regulatory advisory for next-gen cell therapies)
COMPETITION
Position:Niche Player
Competitors:Veristat, Emmes, Novotech, TFS HealthScience, Halloran Consulting Group
LEADERSHIP
Key Executives:
G. Alexander Fleming, MD - Executive Chairman and Founder
Thomas Seoh, JD - Chief Executive Officer
Michael Zemel, PhD - Chief Scientific Officer
Scientific Founders:G. Alexander Fleming, MD
Board Members:G. Alexander Fleming, Thomas Seoh
LINKS
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