Pharmaceutical & Nutraceutical Quality Assurance/Regulatory Consulting.
The Belony Group is a Quality Assurance/ Regulatory Consulting firm committed to helping small to medium pharmaceutical, and large dietary supplememt manufacturers quickly integrate new requirements, equipment, utilities, manufacturing processes and vendors into their quality systems while ensuring strict compliance to applicable good manufacturing practices (GMP). We provide value by reducing implementation time, increasing quality through minimizing errors and omissions. Our consultants have spent years working in the pharmaceutical and Nutritional Supplement industries. This industry focus and depth of functional expertise allows us to “hit the ground running” on complex projects. Moreover, we can provide the added benefit of reducing regulatory non-compliance risk critical to the future growth and reputation of every manufacturing firm in the industry.
Functional Areas include:
Quality Systems Regulatory / cGMP Compliance
Foreign and Domestic Product Registration
Foreign Firm US Agent Representation Services
Quality System Development and Management
Internal and External Auditing
Raw Materival Vendor Qualification
Contract Laboratory Qualification/Method Validation Assistance
Laboratory Good Laboratory Practices(GLP) Audit
Validation Master Plan implementation
Process Validation Assistance
Technical Development and Protocol Writing
From our office in Miami, FL, we serve clients throughout North America. Our clients range from small to medium sized firms throughout the Northeastern Seaboard. The firm provides consulting services for vendor qualification, internal audits, utility and equipment qualification, process validation, product registration, firm registration, quality systems development, facility qualification, software validation, company scale cGMP training, IT system configuration, 21 CFR part 11 compliant software solutions, small business development, legal representation and product development. We have a tiered pricing structure based on the size of the company and the project scope. Services can be priced based on time and material or on a per project basis.
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We'd like to learn more about you and have an opportunity to more thoroughly introduce ourselves. To initiate a call or meeting, please contact us at
1(305) 764-5652, or send us an E-mail at
ContactUs@thebelony.com
The Belony Group LLC.
Phone (305) 764-5652
Fax (305) 836-1713
18520 NW 67th Avenue
Suite 182
Miami Lakes, FL 33015