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Dr. Julianne Lindemann

16 Hammond Pl.

Moraga, CA 94556

USA

Tel: 925-377-5523

Email: JL@nfbconsultants.com

Julianne Lindemann, Ph.D. has 25+ years of experience in research, food safety and regulatory affairs.

PROFESSIONAL

EXPERIENCE:

2006-2010 Director of Regulatory Affairs, Efficas, Inc.

Directed the corporate regulatory compliance program for novel nutritional products. Expertise in GRAS, DSHEA, medical foods, claim substantiation, regulatory due diligence, clinical trial design, FDA facility registration & import prior notice rules, FTC compliance, labeling. Completed 3 GRAS self-affirmations.

2001-2006 Principal, Life Sciences Alliance.

Consulting in regulatory affairs, nutrition, and clinical evaluation. Acting Regulatory Director (2003–2006) & initiated clinical research program for Efficas. Completed NDI Notice (DSHEA).

1997-2000 Monsanto Co. Nutrition & Consumer Sector.

Clinical Lead. Responsible for clinical development strategic planning, experimental design, and execution of clinical trials.

Clinical Nutritionist. Evaluate bioavailability, mode of action and clinical relevance of natural bioactive compounds.

1992-1994 Regulatory Affairs Manager, Calgene, Inc., Oils Division.

Responsible for corporate compliance for edible oils with modified fatty acids composition. Won FDA & USDA clearances for Laurate canola.

1989-1992 Lindemann Consulting.

1994-1997 Consultation in regulatory affairs and nutrition for the agricultural biotechnology industry. Expertise

 in health effects of lipids, dietary exposure analysis, food and feed safety, regulatory agency relations, labeling, risk assessment.

1983-1989 DNA Plant Technology Corp./Advanced Genetic Sciences, Inc.

Director of Regulatory Affairs. Directed the corporate program for regulatory compliance. Founding Member of International Food Biotechnology Council Board of Directors.

Project Leader in Biological Control Group (1984-1987). Responsible for scientific oversight and regulatory compliance.

Postdoctoral Fellow (1983)

1981-1982 Postdoctoral Research Associate, Univ. Wisconsin, Madison.

 

EDUCATION: University of Wisconsin, Madison, Ph.D. (1981)

University of California, Berkeley, B.A. (1976)

HONORS: High Honors (Botany), Distinction (General Scholarship) 1976

Phi Kappa Phi, 1981.

Gamma Sigma Delta, 1980.