Nutraceutical | The Belony Group

Regulatory / cGMP Compliance

We offer customer and FDA audit hosting assistance. Our regulatory compliance service is centered mainly on helping our customers host quality audits that showcases the strengths of their quality management systems and documentation program. We understand that in bidding for new product and technical services, the audit process is a necessary hurdle that must be successfully managed. Our firm will coach and guide your internal staff before and during a customer audit to win the potential business. We partner with your Quality and Sales staff early in the bidding process to ensure that the necessary systems are in place to support the eventual customer or government audit.

A-la-carte services

Active	Item Name	Price
	Cosmetic Firm FDA Registration Description: Registration of cosmetic firm with FDA.	$1,500.00
	Cosmetic product Import Permit Description: Application and obtaining of Import permit for Cosmetic product.	$200.00
	Cosmetic Product Registration (Additional) Description: Listing of cosmetic product for foreign firms outside of the US after first.	$500.00
	Cosmetic Product Registration (foreign firm) Description: Voluntary registration of cosmetic product imported into the US.	$2,500.00
	Dietary Supplement Firm FDA Registration Description: Registration of Dietary Supplement firm with FDA	$3000.00
	Dietary Supplement product Registration Description: Dietary supplement FDA Listing	$3000.00
	Dietary Supplement product Registration (Additional) Description: Listing of dieatary supplement product after first.	$625.00
	Label Revision - Primary Package Description: Nutrition Labeling, Statement of Identity and Ingredient Labeling. Nutrient Content and Health Claims, Comparative Percentage Claims, and Mandatory Structure/Function Claim Disclaimer. Requirements to Use the Nutrient Content Claims "High Potency" and "Antioxidants". Mandatory Warning Statement for Iron-containing Supplements and Special Packaging Requirements for High-Potency Iron Supplements. Nutrition Labeling of Dietary Supplements on a `Per Day'' Basis.	$410.00
	Label Revision - Promotional Materials Description: Nutrition Labeling, Statement of Identity and Ingredient Labeling. Nutrient Content and Health Claims, Comparative Percentage Claims, and Mandatory Structure/Function Claim Disclaimer. Requirements to Use the Nutrient Content Claims "High Potency" and "Antioxidants". Mandatory Warning Statement for Iron-containing Supplements and Special Packaging Requirements for High-Potency Iron Supplements.	$350.00
	Laboratory FDA Registration	$1,500.00
	New/Revised Product Label - Unit dose Description: Review of unit dose or blister Label for FDA/FTC requirements.	$100.00
	Quality Management Systems Benchmark Description: Provide support for the purpose of gathering, analyzing and reporting data to support firm’s compliance with applicable GMPs and ranking the company’s performance against industry players or key competitors.	$5,500.00
	Quality System Audit (Cosmetic) Description: Full GMP Audit of All Quality Systems.	$8,000.00
	Quality Systems Audit (Dietary Supplement) Description: Full GMP Audit of All Quality Systems	$10,000.00
	Regulatory Label Review - New products Description: Nutrition Labeling, Statement of Identity and Ingredient Labeling. Nutrient Content and Health Claims, Comparative Percentage Claims, and Mandatory Structure/Function Claim Disclaimer. Requirements to Use the Nutrient Content Claims "High Potency" and "Antioxidants". Mandatory Warning Statement for Iron-containing Supplements and Special Packaging Requirements for High-Potency Iron Supplements. Nutrition Labeling of Dietary Supplements on a `Per Day'' Basis.	$500.00

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