Pharmaceutical | 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
	DEA Licensing Services Description: Assist company in attaining DEA licence from application through inspection including routine re-inspection.	$8000.00
	DEA Registration Services Description: Register firm with DEA and obtain certificate.	$3500.00
	Drug Firm FDA Registration Description: Registration of OTC and Rx drug firm with the FDA.	$5000.00
	Drug Product Registration Description: List Drug products with the FDA including Annual update	$3500.00
	Drug Product Registration (Additional product) Description: Listing of additional product beyond first.	$750.00
	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 (Pharmaceutical) Description: Full Service GMP Audit of All Quality systems.	$12,000.00
	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
	US Agent Services (1-2 lots) Description: Maintains Documentation records and handles FDA requests for products.	$1,000.00
	US Agent Services (3-5 lots)	$2,500.00
	US Agent Services (6-10 lots)	$7,500.00

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