Entering the Dietary Supplement Market as a Startup - Product development, Planning for Regulatory Compliance

At the end of this course, you will know and understand:

• 21 CFR 111 regulatory requirements for dietary supplement products to enter the industry
• The financials required to develop, manufacturer and launch dietary supplements using cost calculations
• How to determine and develop product user requirements for use throughout the development process

Course Outline

Physical Form

• Packaging
• Dosage
• Benefits (what health claims will be made)
• User requirements for use
• Projected volume
• Marketing costs

Regulatory Requirements

• Does this product contain a new dietary ingredient (NDI)?
• Health claims

Financial Considerations

• How much will the market pay?
• Can I make this product with existing equipment?
• Is the new product a copy of an existing one?

Cost of Components

• Fixed costs
• Product development cost
• Marketing costs

Preliminary ROI Calculation

• The decision to begin development

Specification Development

• Final product
• Components
• In-process
• Analytical method development
• Process design
• Engineering design
• Cost calculations
• Capital
• Marketing
• Cost of goods sold
• Final ROI calculation

The decision to commence production/sales

Conclusion

Resources

This dietary supplement product development training is suitable for:

• Entrepreneurs
• Management
• Manufacturing
• Quality control/assurance
• Packaging
• Marketing
• Laboratory operations
• Auditing
• Suppliers and distributors
• Regulatory affairs