Bio Evaluation BO AB can evaluate, select and set up and follow up assignments with CMO and CRO for manufacturing according to your company’s requirements. 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.
Bio Evaluation can set up service agreement for manufacturing 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. If Bio Evaluation has had the responsibility for process development, your company’s goal for COGs can be secured for commercial manufacturing.
Your process will be designed, from start according to QbD, GOGs and regulatory requirements. Fulfilling that is required for scale to an industrial process for commercial manufacturing.
Bio Evaluation can secure manufacturing that will fulfil regulatory requirements, specification for API / DP, cost and timeline according to the contract, for each phase. In suitable scale for your need of product.
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.