The Gallus Quality department consists of four major teams – Quality Control, Quality Assurance, Quality Systems and Regulatory. Gallus’ Vice President of Quality and Regulatory has responsibility for these Quality teams and reports to Gallus’ President & CEO.
The Gallus Regulatory team supports clients by providing a wealth of services from project strategic consulting through submission of regulatory IND, NDA and BLA documents. This includes delivery of submission-ready CMC reports of the manufacturing process utilized for production of the API, plus management and conversion of pre-clinical and clinical documents comprising a submission. The Regulatory team provides:
Communication: We utilize SharePoint, VPNs and the cloud to foster rapid, accurate and frequent communication with clients to ensure everyone is on the same page.
Security: We have our own FDA-approved electronic submission gateway (ESG), which allows us to communicate with the Agency through an electronic private channel.
Responsiveness: We have been approved by the FDA to submit IND, NDA and BLA documents directly through to the appropriate FDA division for review. This means our submissions are available for response in the shortest time possible.
Consistency: We utilize the same validation software as the FDA, so submissions we compile and validate will not be rejected because of internal programming issues.
Consulting: Senior-level personnel, who are expert in providing strategic regulatory support for navigating the FDA, EMA and other agencies, are available. Our CMC team provides support focused on strategic issues for protein product development.