BGF Consulting proposes to provide comprehensive direction and support for all activities related to Quality Assurance and Quality Control as required in support of the warning letter for both manufacturing operations and Regulatory requirements. BGF Consulting will provide resources with a strong quality and regulatory background and relevant industry experience; a dedicated point-person from BGF Consulting will be assigned to the project. Pre-approved timelines will complete work.
BGF is a group of consultants with direct industry experience who provide regulatory compliance and project management expertise to assist organizations in driving project completion and preventing and remediating compliance challenges. BGF helps organizations understand current regulatory expectations and provides common-sense, streamlined solutions that can be efficiently sustained.
Our consultants provide hands-on assistance, project management and regulatory strategies to drive projects to efficient and compliant close. The multi-disciplinary team's bandwidth enabless us to provide expertise in validation, regulatory compliance and approvals, quality systems and GMPs, analytical and microbiological analysis, and process development and improvement.
BGF works domestically and internationally with companies operating within regulated environments, such as pharmaceutical, compound pharmacies, medical devices, biotechnology, food, and dietary supplement companies.