REGULATORY COMPLIANCE

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.

  • DEA LICENSING ASSISTANCE

    Provide the necessary guidance for implementation of security and record keeping measures to obtain DEA licensing. Prepare and train designated personnel to serve as key individuals in your control of listed or controlled substances. Prepare site for DEA pre-approval inspection. Host or assist in site inspection to ensure positive outcome.

  • THERAPEUTICS GOODS ADMINISTRATION (TGA) CERTIFICATION ASSITANCE

    In order to distribute dietary supplement products in Canada, Australia or the Pacific Rim, this certification is indispensable. Canada requires pre-approval of dietary supplement products manufactured in the US. However, due to mutual recognition agreement with Australia, a firm who distributes product in Australia may also distribute product directly to Canada without pre-approval of the specific product. This certification provides great advantages over competing manufactures without it. We will assist in creating your site master file and provide guidance for implementation of TGA compliant quality system. Prepare firm for TGA inspection. Assist or provide guidance during the inspection process. Respond or assist in any responses to post-inspection observations if any.

  • DRUG FIRM & PRODUCT REGISTRATION

    The Belony Group, LLC (TBG, LLC) register and obtain FDA FEI numbers for manufacturing facilities to simplify engagement in pharmaceutical manufacturing activities on the interstate market as well as assist in obtaining state specific drug manufacturer registration. In conjunction with this service, TBG, LLC will obtain site specific labeler code enabling companies to issue product specific national drug code numbers for every product. Label information submission in the correct approved FDA format along with drug product listing will ensure the ability to distribute products manufactured by firms for private label or own-brand, and that these meet the regulatory requirements for commercial distribution.

  • US AGENT SERVICES

    Our firm will act as your own regulatory affairs department, engaging with the FDA directly with any questions they may have about specific batches distributed in the US. As your representative we will assist with any re-quests for samples or direct discussions with customs personnel concerning your product. Maintain records of batches distributed in the US in order to resolve any potential problems or provide answers to critical issues the agency may have.

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
banner 1
NEWS
up down
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

Map Location