Bio Evaluation BO AB can take responsibility to set up and follow up assignments with CMO and CRO companies for process development for your company. Bio Evaluation has an extensive know-how concerning that is required for development and producing biopharmaceuticals for clinical trials and commercial manufacturing, adapted for the requirement per clinical phase I – IV.
Secure what the process fulfil cGMP, QbD, PAT, quality and regulatory demands for each phase. The process can be scaled up to required capacity. After optimisation fulfilling your company’s COGs requirements for commercial manufacturing, as an industrialised manufacturing method.
Bio Evaluation can set up service agreement based on deliverables, not activities. The cost for the assignment is defined; no extra activities / cost can be added. For the benefit of your company, as well as your investors, when performing the next phase in your companies development. Bio Evaluation can take care of all these issues for your company as advisor or take the full responsibilities for all issues.
Please contact Jan Gunnar Gustafsson for a non binding discussion how Bio Evaluation can support your company.