Pharmaceutical

BGF Consulting has an unsurpassed reputation for excellence in technical, regulatory consulting, and guidance services for the Pharmaceutical Industry, including generic and new drug products, OTC, and monograph drugs, and many more.

BGF is proficient in the development, implementation, and management of diversified projects involving compliance, scientific principles, technical aspects, and regulatory requirements related to pharmaceutical products.

Medical Devices

BGF Consultants’ comprehensive list of services extend to all classes of medical devices  and combination products including In Vitro Diagnostics, Integral, Cross-labeled and Kitted Combination Products.

Our wide range of combination product consulting services serve areas such as medical products, SaMD, materials and components, processes and mechanical engineering and manufacturing, design history, as well as testing and validation.

Regulatory Affairs

EXPERIENCE. EXCELLENCE.

Our Regulatory Affairs consulting group is comprised of former senior-level FDA managers, FDA reviewers, and industry experts. Our goal is simple; provide simple, workable solutions for client’s regulatory problems or issues at the highest levels of efficiency and excellence.

Services and features include advising on a full range of regulatory compliance and scientific issues related to generics (including complex generics) and new drugs, as well as prepare and/or provide assistance in the preparation and electronic submission of all types of FDA regulatory documents, including drug applications, e.g., ANDAs, NDAs (5050(b)(2) and 505 (b)(1)), DMFs (Type II, III, IV), and other FDA regulatory forms.