Glen Freiberg

Mr. Freiberg serves as Ciniva Health's Regulatory Affairs Consultant.  Currently, the President of San Diego based RCQ Consulting; he was previously the Vice President of Regulatory Affairs with Gen-Probe Diagnostics.  Mr. Freiberg brings to Ciniva a long and successful history of launching new products to the United States health and fitness market.

Prior to joining Gen-Probe, Mr. Freiberg served as Vice President of Regulatory, Clinical, and Quality Systems for C.R. Bard from 1993 until 1998. He has held industry positions in areas regulated by three FDA Centers: Drugs, Biologics and Medical Devices. Mr. Freiberg also previously worked at the FDA as an Investigator in the Boston District, and has served three terms as the Industry Representative on FDA Advisory Panels, first for the Clinical Chemistry/Toxicology Panel, then for the Immunology panel.

Mr. Freiberg received his B.A. in biology and an M.A. in microbiology from the University of Colorado, Boulder, and is co-founder and past President of the San Diego Regulatory Affairs Network. He joined Gen-Probe in April, 1998 as Senior Director, Regulatory Affairs and remained in that position until he was named Vice President — Regulatory, Quality and Government Affairs in October 2001.

The LDI Group

The LDI Group of Utah, United States is a consulting company to Ciniva Health Systems.  They are expert in a variety of regulatory areas, including:

  • Structure/function claim, development review, and submissions
  • Supplement Facts Box set-up and reviews
  • Ingredient safety reviews
  • Old Dietary Ingredient status review and confirmation
  • New Dietary Ingredient submissions
  • Quality standard and GMP compliance
  • Analytical method assessment and development
  • GRAS affirmations for dietary ingredients
  • Nutrition Facts Box set-up and reviews
  • Health claim and qualified health claim compliance and development
  • Nutrient content claim evaluation
  • Advertising review and compliance evaluations
  • Claims substantiation reviews
  • Technical expert reviews and opinion letters
  • Product or ingredient reviews for Proposition 65 heavy metal level compliance
  • Updates on Prop 65 cases affecting dietary supplements and functional foods
  • Bioterrorism compliance
  • Facility registrations
  • Prior notification of importation advice
  • Record keeping requirements compliance
  • Registered agent services
   

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