Strategic R&D Planning

Consulting clients in setting-up and driving their overall R&D strategy for e.g. generic or biotech drugs, taking into account the financial constraints and limited time in the R&D area.

Target clients: pharmaceutical companies, especially small and medium sized ones, and other organisations which are or intend to collaborate on the development of generic or biotech drugs.

The strategic planning services, include but are not limited to the following activities:

  • Independent R&D project evaluation, selection and definition

  • Portfolio analysis and risk assessment

  • Strategic concepts for portfolio optimisation (development programs, in-/out-sourcing, efficiency projects)

  • Evaluation and consultation with special emphasis on CMC, biopharmaceutics and pharmacokinetics

  • Lean CMC and clinical development to optimise investment and time

  • Consultancy with regard to strategic registration issues: National Procedure, Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), Centralized Procedure (CP)

  • Development and implementation of regulatory strategies with special focus on Europe, furthermore experience exist also for Asia Pacific and United States

  • Clinical development strategy

  • Gap analysis for submission documentation and in-license activities (due diligence activities)

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