This workstream offers a safe environment for CMC regulatory professionals to address key topics to improve industry license application processes.
Delayed submissions and product approvals
Industry may not be consistent or up to date with regulatory expectations, concerns or trends. If submission details and/or formats are not appropriate this can delay approval timelines with increased questioning and differences in interpretation.
Achieving timely submissions and faster approvals
Within the constraints of the Common Technical Document (CTD) format, members learn from each other and incorporate a Quality by Design (QbD) approach to compiling successful Biologics Licensing Application (BLA) submissions.
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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