Analyses & Characterisations
Bio Evaluation BO AB can take responsibility to set up and follow up assignments with CMO and CRO companies for analytical development and characterisation for your company. Bio Evaluation has an extensive know-how concerning which analyses that are required for development and control of biopharmaceuticals for clinical trials and commercial manufacturing, adapted for the requirement per clinical phase I – IV.
Successful process development and manufacturing are depending on accurate and relevant analyses methods are in place. Bio Evaluation can set up the specifications that are required for each clinical phase and secure that the required analytical tools are developed. Methods what can be validated and secure proper process validation. Analyses and characterisation is crucial for approval of API and DP for clinical trials. Characterisation per phase is a requirement for shoving comparability between the API/DP used in the clinical phases or at different manufacturing sites.
Bio Evaluation can set up service agreements based on deliverables, not activities. The cost for the assignment is defined; no extra activities / cost can be added. 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.