Professional Experience:
                                   
3/96 - Present              Jeiven Pharmaceutical Consulting, Inc.
                                    Senior Consultant
 
Auditing of contract manufacturers (for excipients, active pharmaceutical ingredients and drug products), analytical laboratories, packaging and labeling facilities (for clinical and commercial operations), and controlled drug substances (procedures, personnel and facilities); conducting courses on controlled drug substances for DEA compliance.
 
1/83 - Present              Medipharm International Consultants, Ltd., New Rochelle, NY
                                   President
 
Consultant to domestic and foreign pharmaceutical/chemical companies, including manufacturers of ethical and OTC pharmaceutical products, bulk active pharmaceutical ingredients (APIs) and intermediates. Controlled Substances, vitamins, herbal and dietary supplements, medical devices and cosmetics.
 
Preparation, submission and monitoring of Drug Master Files, IND’s, Form 6’s, NDA’s and ANDA’s; development and implementation of Standard Operating Procedures (SOPs) which conform to FDA and International Good Manufacturing Practices; pre-approval inspection (PAI) facility audits to determine the level of compliance required to conform to such regulations; contact with the Drug Enforcement Agency (DEA), Consumer Product Safety Commission, and Environmental Protection Agency (EPA).
 
Experienced in acquisition, evaluation, strategic analysis and technology assessment; active participation in market analysis and market research studies.
 
12/99 - Present           HP Capital Markets Group Ltd.
                                    Senior Vice President - Pharmaceutical Business Development
 
3/96 - Present             Jeiven Pharmaceutical Consulting Inc.
                                    Senior Consultant
 
6/90 - Present             Cox & Fay, Inc./Technology Transfer, Inc.
                                    Principal-Regulatory Compliance
 
3/84-6/86                     Dell Laboratories/American Geriatric Drug Co., Teaneck, NJ
                                    Vice President, Operations
 
3/80-12/82                   Edward Mendell Company, Inc., Carmel, NY
                                    Vice President
 
3/77-3/80                     The Vitarine Company, Inc., Queens, NY
                                    Director of Regulatory Affairs and Quality Assurance
 
3/64-3/77                     Manhattan Prescription Center, New York, NY
                                    Owner/Pharmacist of this ethical prescription pharmacy
 
Education:                   June, 1958       Columbia University College of Pharmacy
                                                            Bachelor of Science degree in Pharmacy
 
Memberships:             National Association of Pharmaceutical Manufacturers
                                    Parenteral Drug Association
                                    International Society of Pharmaceutical Engineers
                                    Regulatory Affairs Professional Society
                                    Nonprescription Drug Manufacturers Association
                                    Chemist’s Club
                                    Columbia University College of Pharmaceutical Sciences
                                    Alumni Association

 

Biographical Sketch