In addition to providing services in pre-clinical process development, production and product characterization, Batavia Bioservices also leverages the many years expertise its personnel have gained in directing and leading biopharmaceutical product development to offer full project management capabilities and services to customers wishing to outsource or receive advice on the complete product development trajectory.
We offer our expertise to assist the client in preparing a full product development plan leading all the way to initiation of phase I clinical studies. As part of this plan and together with our strategic partners, our expertise can be used to make a complete project plan in which all required activities are fully integrated including process development, clinical manufacturing, safety and efficacy studies, regulatory and clinical strategy etc.
Through the creation of such a project plan, we can assist clients in timeline and budget estimations, in the definition of the target product profile, design of the process development strategy with a view towards clinical and commercial manufacture, design of the product characterization requirements, the required safety and efficacy data packages and potential clinical trial designs.
Once the project has been initiated, we offer full project management capabilities that can used to manage all the activities in the project including parts that are performed outside of Batavia Bioservices, either through our strategic partners or through the selected or preferred partners of the client. This may include budget and timeline tracking, organization of project team meetings and project reporting and scientific and milestone monitoring.