utraTec provides a team of experienced and knowledgeable regulatory professionals. They advise on regulatory strategy during the product planning and development stages. They also, help with the regulatory submission process to obtain required approvals from regulatory agencies for food and pharmaceutical products.
Regulatory Strategy:

• Advise on the type of information necessary and the preferred format for successful submissions to the FDA to comply with NLEA, DSHEA, Medical Foods, OTC, and Drug regulations
• Negotiate with FDA officials to resolve issues raised during the review process

• Develop "health claims" for foods
• Prepare "structure-function claims" for dietary supplements
• Develop "benefit claims" for medical foods

• Assemble and review scientific support documentation for health and structure-function claims
• Prepare safety and clinical summaries and final study reports
• Assist in the organization and assembly of FDA submissions
• Aid in the preparation of Annual Reports for marketed pharmaceutical products

• Assist in the development of in-house procedures for GMPs, GCPs, and GLPs
• Conduct on-site audits in preparation for regulatory agency inspections