We provide experienced Project Managers that are reliable and flexible to assist our customers in the production and characterization of biotherapeutics to meet current regulatory guidelines and expectations. With our strong focus on customer timelines and needs, we find solutions to projects’ issues in a proactive, timely and responsive manner.
Bioworkshops will assign a dedicated Project Manager to each project based on the team members' technical expertise and project needs to ensure that customers’ needs are fully met. The Project Manager will act as a single point of contact for all external parties to accelerate the execution of the project, ensuring precise communication throughout the entire process. Our rigorous information security controls and modern IT infrastructure assure efficient, secure, and confidential delivery of the project.
Our project management team has full lifecycle project management experience for antibody drug development covering early CMC research, IND filing, clinical research, late-stage CMC research, NDA/BLA filing, product launch, and post-market changes for China, the United States, Europe, and Australia.
They use their practical experience to optimize the project plan for each project, including standardized PMP® risk management processes, to expertly coordinate all CMC deliverables, regardless of whether the scope is for initial IND filing or commercial-stage production.