Quality Assurance Services.
In addition to ensuring internal compliance with federal regulations and international standards, TBG provides quality and compliance services to our clients. Whether compliance consulting or vendor auditing, writing a single SOP or developing an entire quality management system, or training and certification, quality services are under the direct supervision of The Belony Group quality and compliance.
Regulatory Services.
To ensure consistency of quality standards, promote synergy in meeting client expectations and provide a clear picture of challenges to Top Management, quality and project management are driven from the. Validation Solutions management is responsible for product realization, internal quality control and management of individual projects, but overall quality policy, regulatory compliance, internal auditing, project management processes and metrics, corrective actions, and Top Management review are all driven at the corporate level to ensure consistency and independence.
Company Profile
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.
To request a free qoute or GMP gap analysis:
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
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
- Software Validation
- Technical Development and Protocol Writing
- cGMP Training
