BLA: Gaining FDA Approval for Biologic Products
A Biologics License Application (BLA) is a request to the U.S. FDA to introduce a biologic product—like vaccines, blood products, or gene therapies—into interstate commerce. It involves rigorous documentation, clinical data, and compliance with quality standards.
KanBo centralizes every step of the BLA process—gathering clinical data, compiling regulatory documents, and coordinating with legal teams. In Workspaces, you can break down each submission requirement into Cards, ensuring tasks are assigned to the right experts. Resource Management helps you schedule internal reviews and manage external consultants. By uniting daily regulatory tasks with high-level milestones, KanBo helps keep your BLA submissions efficient, compliant, and on track for approval.
Streamline BLA Submissions with KanBo
Streamline BLA Submissions with KanBo
KanBo centralizes every step of the BLA process—gathering clinical data, compiling regulatory documents, and coordinating with legal teams. In Workspaces, you can break down each submission requirement into Cards, ensuring tasks are assigned to the right experts. Resource Management helps you schedule internal reviews and manage external consultants. By uniting daily regulatory tasks with high-level milestones, KanBo helps keep your BLA submissions efficient, compliant, and on track for approval.
KanBo Installation Options
The KanBo Platform boosts efficiency and optimizes work management. Whether you need remote, onsite, or hybrid work capabilities, KanBo offers flexible installation options that give you control over your work environment – all while meeting the highest security standards.
On-premise Installation
The best option for highly regulated organizations and public sector entities. KanBo’s on-premise installation allows organizations to maintain 100% control over their data and infrastructure. This is ideal for companies or IT teams that need absolute oversight, ensuring that sensitive information stays entirely within your managed environment.
Cloud Installation
The best option for fast and flexible deployment. Access KanBo software via a cloud provider managed by your IT team. This installation option enables easy scalability and the ability to access KanBo from anywhere, making it a great choice for organizations that prioritize agility and convenience while still maintaining robust security measures.
GCC High Cloud Installation
The best option for regulated industries. Access KanBo securely via Microsoft’s GCC High Cloud, designed specifically to meet compliance with federal standards like FedRAMP, ITAR, and DFARS. This installation is perfect for government contractors, defense, and other industries that require the highest levels of data protection and security.
Hybrid Installation
The best option for maximizing flexibility and security. Enjoy access to two KanBo instances – one self-hosted and one hosted on Microsoft’s infrastructure, including GCC High Cloud. This hybrid installation allows you to separate sensitive and non-sensitive data while ensuring scalability and robust security for each environment.
Roadmap for Implementation
Planning and Setup
Pilot Phase
Pilot Evaluation
Full Rollout
KanBo – Work Coordination Platform
KanBo is a work coordination software designed to help self-organizing teams work smarter and faster. You can see KanBo in action by accessing our demonstration environment.