Drug Development Planning and Strategy

A typical drug development program starts with a thorough review of the available data. This is followed by the design of a ‘roadmap’ or drug development plan that outlines the essential minimal package required (bio)chemical and pharmaceutical, nonclinical and clinical studies, including possible biomarker development, drug formulation requirements, regulatory requirements, quality assurance, timelines and the risks and costs that are associated with the development of the product up to a certain milestone. Optionally, a modeling and simulation approach may also be addressed in the drug development plan.

More specifically we do provide:

•  Evaluation of target validation
•  Review of Target Product Profile
•  Completion of Gap analysis
•  Establish customised development plan (studies, budget, timelines)
•  Establish regulatory compliant strategy
•  Optimize Intellectual property strategy
•  Project risk assessment and risk mitigation strategy
•  SWOT Analysis
• Risks and mitigation analysis