Strategic Planning

We provide a road map and guidance for all stages of drug discovery and development to produce a plan that is compliant and at the same time pragmatic. Keeping the end objective in mind, we ensure your plan is tailored to the desired clinical and regulatory outcome, as well as the company’s objectives. Our services include:

• Gap analysis of existing data
• Discussing your objectives and establishing a regulatory strategy meeting your end goal
• Defining the target product profile (TPP)
• Providing a customized development plan, complete with realistic timelines and estimated budget
• Assessing risks and ways to mitigate

Execution

We can act as your internal scientific officer and execute the discovery and development plan together with your team or we can advise and guide your team as needed. We can directly manage internal and external vendors or provide support in order to achieve your company’s milestones:

• Research stage:
  • Hit and lead identification
  • Mechanism of action
  • Proof of concept activity in the desired clinical indication
  • Early in vitro ADME characterization
• Pre-clinical stage:
  • Recommend vendors and CMOs for Chemistry, Manufacturing and Controls (CMC) and pharmaceutical development and supervise their work
  • We advise on the required pharmacology studies and interpret the results
  • Pre-IND meeting preparation and EMA scientific advice meeting preparation and documentation
• Clinical development:
  • We can provide a tailored clinical development plan which can be included in the discussion with global authorities
  • Assistance with CRO selection
  • Clinical trial strategy and synopsis writing