Regulatory & CMC Support
GBI has worked with clients around the world and provides expert support to help you quickly and effectively move your drug candidates through the regulatory application and review process. Our staff members are knowledgeable about regulatory requirements and guidelines for products produced using novel platforms in the United States, Canada, Europe, Australia, Asia, and other major territories.
Our regulatory support services begin with the preparation of Chemistry, Manufacturing, and Controls (CMC) information for IND filings and amendments. We provide regulatory CMC assistance in all aspects of client projects, including meeting with regulatory agencies to discuss CMC development, manufacturing, and testing. GBI has also provided late-stage services for BLA filing and is expected to launch our first commercial products in 2023 on behalf of our clients.
GBI’s FDA Drug Master File and Site Inspections
GBI has established a Drug Master File (DMF) with the FDA and our team has substantial experience in submitting type II DMFs, DMFs for active pharmaceutical ingredients and drug products, and INDs for biologic products. Our site has been inspected by the FDA and other national health agencies to enable our products to be used by customers in the US, Canada, Europe, Asia, Australia, and many other regulated markets.