In 1972, Goldner co-invented both the liquid form of methadone as well urine screening. As founder of Regulatory Affairs Associates LLC, a consulting firm for companies seeking regulatory approval from the FDA, Goldner has helped get more than 240 drugs and devices approved and in doing so helped create over 200 companies with over 10 000 employees.
Stephen Goldner has served as FDA Advisor to the NIH, advising medical device and drug developers and grant awardees.
Stephen Goldner - Career History
FDA/NIH Adviser
FDA
2010 - present
Stephen provides expert FDA advice to over 100 NIH phase 2 grant awardee groups in order to bring their inventions through FDA approval.
Founder and President
Regulatory Affairs Associates LLC
2001 - to date
An uniquely successful consultancy that has helped gain FDA approval for hundreds of medical devices and drugs.
Founder, Chairman & CEO
CureLauncher
2011 - date
A free, consumer-friendly resource that connects patients to clinical trials based on their unique goals and conditions through the use of live “relationship managers.”
Chairman, USA Cannabis Laboratory Standards Setting Committee
FOCUS Foundation Of Cannabis Unified Standards
Nov 2014 present
Chairman, USA Cannabis Clinical Trials Standards Setting Committee
FOCUS Foundation Of Cannabis Unified Standards
Nov 2014 present
FOCUS (Foundation Of Cannabis Unified Standards) is the first and only national organization to develop accredited quality and safety based cannabis standards. FOCUS Mission is to protect public health, consumer safety and to promote integrity within the cannabis industry. FOCUS follows the American National Standards Institute (ANSI) essential requirements in all of their practices. The SCC represents the cannabis and standards industry, regulatory agencies, health departments, medical, research, the public and business sector as well as patients and consumers to form a balanced consensus body developing quality and safety standards for cannabis in eight areas.
Founder and President
C³ LLC December
January 2015 to date
C3 provides business and scientific consultancy services and advice to improve the safety and efficiency of the growing plants industry. Advisors to Cannabis growers, dispensaries and processors.
Founder and President
Pinnacle Lab LLC
December 2015 to date
Stephen is spearheading the nation’s only cannabis laboratory to have performed FDA validation of its laboratory methods.
Founder, Chairman
Pure Green LLC
January 2016 to date
A vertically integrated cannabis food and drug company operating in Michigan.
Founder, CEO
Cannabis Intellectual Property LLC
November 2015 to date
Cannabis Intellectual Property LLC (CIP) holds the inventive patents ideas from Stephen Goldner in the marijuana field.
Lead Investor
Brainfire LLC
July 2015 to date
Start-up engineering company with best-in-class products for cannabis and other agricultural markets. Based in Detroit.
Vice President, Government Affairs
Ferndale Pharma
1994 - 2001
Vice President, FDA - Regulatory Affairs
ICN Pharmaceuticals, Inc
1989- 1994
Director of FDA Affairs
Unilever
1977 - 1989
Co-Founder and COO
Spectrum Labs LLC
1973 - 1977
Innovator startup in urine screening for recreational drugs’ market
Co-founded with his mentor John Broich who trained and worked at Brooklyn Labs
18 staff. Successfully exited in 1977
Co-Founder, COO
Mifflin Labs LLC
1973 -1977
Innovator company in methadone manufacturing and distribution.
Co-founded with his mentor John Broich who trained and worked at Brooklyn Labs
15 staff. Successfully exited in 1977
Supervisor Forensic Toxicologist
Office of the Chief Medical Examiner, New York City
1970-1973
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Author
Co-author: Drug Pedigrees: Your Supply Chain Needs Them. Are You Ready?
First tier referred journals
Co-author: Liquid-solid extraction of lyophilized biological materials for forensic analysis. Application to bile samples for the detection of drugs
http://www.sciencedirect.com/science/article/pii/0006294474900106?np=y
Co-author: Dual-bed thin-layer chromatography for the separation and detection of drugs of abuse in urine
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Qualifications
Regulatory Affairs Certified since 1985
Doctor of Jurisprudence 1981
Bachelors in Chemistry June 1969