Regulatory Support Services

At GBI, we provide expert Regulatory support to our clients to assist them in quickly and effectively moving their drug candidates through the regulatory application and review process. GBI provides full regulatory support services for projects beginning with process development initiatives in support of toxicology study materials through the preparation of Chemistry, Manufacturing & Controls (CMC) information for IND filings and amendments. Our staff provides regulatory assistance in all aspects of client projects including meeting with regulatory agencies to discuss manufacturing and testing issues. Our staff is knowledgeable in US, Canadian, and European requirements, as well as guidelines for products produced using novel platforms.

GBI can supply all of the manufacturing documentation required for IND filings or provide assistance with specific sections.