QUALITY ASSURANCE

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 top down. 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.

  • DOCUMENTATION SYSTEM DEVELOPMENT/AUDIT

    Assistance can be provided to reinforce an existing system or create a new documentation control system including change management to help your firm meet its record keeping requirements under GMP regulations. Sometimes gaps in these systems when left unresolved result in un-perceived or non-detectable quality deficiencies. Along with our GAP analysis service we provide directed and specific guidance and solutions to ensure your documentation is comparable to major industry players as well as meeting FDA requirements.

  • VALIDATION MASTER PLAN DEVELOPMENT AND IMPLEMENTATION

    We can provide assistance developing and implementing your site validation master plan. Ensure all elements of a good validation program are included, provide technical/protocol writing assistance, and project management to ensure that projects are implemented in a methodical and timely manner. Validation assistance includes software, facility/utility system, equipment installation, operation and performance, cleaning, analytical method and stability chamber validation.

  • QUALITY SYSTEMS AUDIT

    The Belony Group, LLC® (TBG, LLC) performs audits of quality systems to validate and ensure compliance of quality system requirements. The audits are performed in accordance with written procedures. Audit results are documented and formally presented in writing to all key stakeholders and other involved parties who have responsibility for the matters audited. Corrective action, including audit follow-up of deficient matters, will be recommended based on significance of audit findings. To assure that company quality goals are consistently met and comply with regulatory requirements, quality system audits will:

    1. Measure the effectiveness of the quality system
    2. Provide objective evidence that adequate controls are in place
    3. Assure that products and processes conform with specifications.

    Under GMP requirements, manufacturers must include audits of their suppliers, laboratories, calibration service providers, and contractors as part of a comprehensive quality system. We offer supplier audit services, to assure that your suppliers have adequate quality system controls in place.

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
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NEWS
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Company Profile

About Us

The Belony Group provides a complete suite of regulatory and quality solutions designed to make our client’s business simple and successful. Founded in 2008, we strive to be a single source provider of solutions to the pharmaceutical, dietary supplement, medical device and related industries.

We have experienced staff from the pharmaceutical Medical Device and Dietary Supplement Industries. Our team boasts experience in manufacturing, Quality Systems Compliance and Validation. Our senior staff has over 45 years combined industry experience. Key personnel include former head of quality for the third largest soft gel nutritional supplement firm in the United States, Semi-solid CRO/CMO firms as well as Biotechnology firms. Our corporate staff has successfully developed business processes and quality management systems designed to ensure consistency of quality standards, promote synergy and provide clear picture of challenges to our clients.

Quality

We have routinely hosted regulatory agency as well as client audits and spear headed remediation procedures to bring a firm’s compliance standards to appropriate GMP level whether it is to pharmaceutical drug, or dietary supplement standards. Our experience includes, Regulatory Affairs, Quality Assurance, Technical Affairs, Validation and Production.

Your Quality System is the most far reaching of all your business processes. It is the system on which you are most often scrutinized to determine the health and viability of your company. Our firm is poised to help you establish and maintain a healthy Quality System and provide expert guidance to make key decisions.

Project Management Expertise

We are knowledgeable with semi-solids as well as hard and soft oral dosage forms. Our firm has conducted raw material vendor and contract laboratory Quality system audits for key industry clients. We have developed and implemented validation of cleaning, process, utilities and equipment to help the firms meet their FDA regulatory requirements. Moreover, the group has developed procedures for compliant documentation systems, calibration, maintenance programs as well as vendor qualification.

We view our approach to project management as one of the cornerstones of our success. Our Clients have consistently attributed the great success of their projects to the comprehensive and result-oriented project management philosophy that we bring to the table.

Location Information

18520 NW 67th Avenue
Miami Lakes, FL 33015

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