John Harbell

WORK HISTORY

EDUCATION

SKILLS

ABOUT JOHN HARBELL

JHarbell Consulting LLC provides personal care, cosmetic, household products and nutritional supplement companies with product stewardship guidance from ingredient selection/qualification through final formulation development, testing, and required documentation. Client firms benefit from the company’s expertise and experience supplemented with supporting data from selected contract laboratories and, as needed, input from outside subject matter experts. All inquiries and projects are handled with the strictest confidentiality.Services:• Ingredient safety reviews, covering a series of toxicological endpoints, and safety assessments for use in the intended products. Preclinical and clinical data can be developed as needed to complete the assessment. If required, the review can be prepared to merge into an EU Product Information File (PIF).• Formula reviews on the ingredients for acceptability for the product type, monograph approval (i.e, UV filters), concentration and purity. Margin of Safety calculations are prepared where data are available. A program of preclinical and clinical safety testing would be proposed to establish the formula human compatibility for its intended use. • Preparation of regulatory documents for the activities above (i.e. EU PIF part A, Risky Chemical Assessment [China for notified products]).• Design or review of current corporate product safety program(s). Such a review might be driven by entry into a new market (i.e, EU), introduction of products in a more regulated class, or changes in overall market requirements.• Design custom test batteries to address specific, often unique, client requirements. Preclinical testing would focus on in vitro methods while clinical testing would follow current, recognized protocols. Both preclinical and clinical testing would be designed to be acceptable to regulatory authorities when applicable.• Provide cGMP audit review of contract manufacturing facilities.