Regulatory Support (Non-GMP / GMP)

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.

Drug Master Files (DMF's) 

GBI has established a Drug Master File (DMF) with the FDA.

GBI also has substantial experience in submitting type II DMF's to the U.S. FDA, and we have a broad range of experience in submitting DMF's for active pharmaceutical ingredients, Drug Products and IND's for biologic products.  GBI strictly adheres to the regulations associated with the development of every new pharmaceutical ingredient, biologic product.

GBI offers:

• Manufacturing that is fully committed to ensuring that our manufacturing process comply with international regulations for current Good Manufacturing Practice (cGMP).
• Custom Manufacturing operates process oriented quality management systems based upon international quality standards, Our site has been inspected by the FDA and other national health agencies to enable our products to be used by our customers in the United States, Europe, Asia, and many other regulated markets.
• Decades of experience in the analysis of biological materials.
• Experience of performing testing on over 150 recombinant proteins and monoclonal antibodies  per FDA and EU requirements 
• Experienced in handling FDA and EU regulatory agency inspections
• Preparation or review of IND submission documentation (CMC sections)

See what the FDA had to say.

Quality Division

It is the policy of GBI to use appropriate management systems to carry out our mission. Quality is the intrinsic focus of all management practices that make up these systems. These practices include the following elements: proper planning, performance of appropriate tasks, timely assessment, and continuous improvement of established processes. By addressing these elements in the research, development, operations, and support activities, defined goals are met and both the GBI and the client requirements are satisfied. All work is performed with dedication to excellence and with an objective of dynamic and continuous improvement.

Quality Assurance

Each department at GBI involved in GMP manufacturing maintains a quality program that meets its specific needs and is consistent with the guidelines provided in the GBI Quality program. GBI Quality Assurance continually monitors these programs to assess their effectiveness. Quality Assurance is also responsible for review, approval, and control of critical processing steps, component release, and documentation in support of GMP manufacturing. Our quality systems include:

• cGMP Documentation
• Audit and Review
• Approval and Release
• Vendor Audit
• cGMP Training
• CAPA

GBI has established a Drug Master File (DMF) with the FDA.

Quality Assurance maintains programs for vendor qualification, and internal and external audits, as well as procedures for responding to client and regulatory agency audits of GBI operations.

We Welcome Audits

Over the years, we have had more than 85 audits from:

• FDA, as well as Health Canada, the EMEA and other regulators
• Customers
• Auditors

We welcome the opportunity to host an audit from your company or representative.

See what the FDA had to say about our inspection