Technical Project Management

Effective project management is essential to close the gap between corporate strategy and successful value realization. Probiocon provides CMC project management support to ensure that project scope, budget and timelines are planned, monitored, and controlled efficaciously. Depending on your requirements and the phase of your project, our tasks can include:

• Identification and management of stakeholders within and outside your organization
• Planning of project scope, schedule, and cost including appropriate documentation, taking into account (i) the required quality standards for the products´ development stages and (ii) regulatory requirements
• Identification of risks, risk analysis and development of adequate risk response plans
• Close monitoring and controlling of project scope, costs, timelines, quality and risks

Outsourcing Management to CMOs / CROs

Our consultants have managed the transition of many biopharmaceutical compounds (e.g. antibodies, antibody derived proteins, fusion proteins, biosimilars) from research into preclinical and clinical development stages up to market supply. Based on the experience of our consultants gained in key management positions of contract manufacturing and research organizations, we assist our clients in outsourcing activities for the development and manufacturing of their products (API and final dosage forms). Typically, this involves:

• Definition of requirements and selection of most suitable CMOs / CROs
• Preparation and conductance of outsourcing processes
• Management of outsourcing activities
• Preparation of IMPD documents (CMC)