• Business development, food, supplement and chemical industries
• Licensing, joint ventures and strategic alliances
• Technology transfer focusing on foods, supplements and chemistry technologies
• Food, supplement and chemistry technology, marketing and commercialization 
• Expert witness and litigation support on food, supplement and chemical topics

Contact: mcquate@bendbroadband.com

 Richard C. Kraska, Kraska Consultants, Inc.

• Food Additive Petitions and Food Contact Notifications
• FDA Compliance Databases
• Toxicology and Chemical Product Safety
• TSCA and CEPA PMNs
• TSCA Regulatory
• Hazard Communication
• Defoamers
• Metalworking fluids and other lubricants
• Expert witness and other litigation support

Contact: rich@kraskaconsultants.com; www.kraskaconsultants.com

 

Evelyn Cadman, Bioscience Translation & Application

• Food, Supplement and Cosmetic Product Development
• Technology and Market Evaluation
• Patent and Prior Art Analysis
• Food, Supplement, Cosmetic and OTC Drug Labeling
• Claim Evaluation and Substantiation
• Technical Writing

Contact: ECadman@BioTransApp.com; www.BioTransApp.com; www.DSHEAlabels.com

 

Richard A. Davis, Regulatory Toxicology Consultant - ToxSolutions

• Labeling of hazardous art materials
• ASTM D-4236 Certification
• Consumer Products Safety Evaluation
• Inhalation toxicology and Threshold of Concern (TOC)
• Occupational Exposure Standards
• Pharmaceutical Safety Evaluations, IND/NDA Summaries

Contact: Rick@ToxSolutions.com; www.ToxSolutions.com

 

C. K. Gund, Ph.D., and Clyde A. Takeguchi, Ph.D., Co-founders of
Phoenix Regulatory Associates, Ltd.

Phoenix has regulatory expertise regarding all FDA regulated products in addition to the following:

• Submission Preparation:  (FAPs, GRNs, CAPs, INDs, NDAs, DMFs, ANDAs, IDEs, 510(k), PMAs, NADAs, 75-day Notifications, Infant Formula Petitions)
• Perform GxP audits; advise on GxP/QA requirements
• Review manufacturing facilities and/or consult on facility design
• Consult on implementation of efficacy trials
• Advise on Nonclinical Proof of Safety
• Review Product Label and Labeling
• Develop/Manage Responses to FDA’s 483s and Warning Letters
• Assist with the Development and Implementation of Corrective Actions
• Resolve Data Integrity Problems
• Provide Expert and Fact Witness for Litigation

Contact: phoenix@phoenixrising.com, www.phoenixrising.com

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