From Start-Ups to Fortune 100
BGF Consulting specializes in assisting start-ups and small to mid-size companies needing additional personnel without the expense of adding full-time employees.
BGF is a group of consultants with direct industry experience who provide regulatory compliance and project management expertise to assist organizations in driving projects to 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 an efficient and compliant close. The bandwith of the multi-disciplinary team enables 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, medical device, biotechnology, food/beverage, compound pharmacies, and nutritional companies.
Who We Serve
1. Small to mid-size companies including start-ups without an in house Regulatory staff or are in need of additional assistance meeting FDA requirements.
2. Companies receiving 483 Observations and/or Warning Letters. BGF can provide assistance with Quality System and Regulatory issues such as cGMP Violations, Misbranding, Adulterated Products, Quality System Violations, Labeling Issues and Marketing Unapproved Products.
3. Companies requiring specific training to advance their project forward or for Regulatory Compliance.
4. Compound Pharmacies unfamiliar with the FDA requirements.
5. Dietary Supplement companies seeking assistance complying with cGMP requirements.
6. University or Research Groups needing Regulatory and Compliance support to provide for the commercialization of their product.
University Research and Development Programs