1.618 Consulting: Capabilities

Capabilities

  • Development or assessment of strategy
  • Evaluation of potential program(s)
  • Selection of initial or subsequent disease targets
  • ​Development of clinical and regulatory development plans
  • Prescription to non-prescription switches — evaluation of candidates, program design
  • Preparation for advisory committee and other regulatory meetings including background documents, rehearsals, Q&A and actual meeting attendance (FDA, EMEA,MHRA and other competent national authorities)
  • Responses to regulatory communications including requests for additional data
  • Evaluation of existing portfolio, program or data to assess the chance of success, and identify weaknesses or gaps in data.
  • Due diligence evaluation
  • Critique of documents for submission
  • Development of scientific and commercial strategies for product differentiation
  • Adjudication of divergent intra-company views as objective outsider
  • Support for scientific litigation
  • Evaluation of claims
  • Organizational and Process Development