We offer a comprehensive service portfolio covering all stages of pharmaceutical development:
- Interim Management
- Regulatory Interactions
- Designated Sponsor
Translational project management from the laboratory bench to clinical development.
Translational Project ManagementOur translational project management method includes all steps necessary for successful development of a new pharmaceutical or active pharmaceutical ingredient – starting from bench, followed by a GMP-compliant production and pre-clinical testing up to the clinical development phase.
- Step 1: Definition of product profile using clinical target parameters, in-depth market analysis and assessment of the competitive parameters, including patent evaluation.
- Step 2: Detailed reverse planning starting from market and approval strategy backwards to the development of pre-clinical and clinical trials.
- Step 3: Operational project management with cost-controlled working packages and milestones. Pre-defined critical “tollgates” keep development risks low during project management.