Customized to Your Needs

  • Consulting focused on specific Milestones, projects and roles

  • Ongoing advisory capacity

  • Part-time or interim CMO or clinical leadership roles

Services Include:

  • Drug development strategies and plans

  • Clinical study design and synopsis/protocol development

  • Interpretation of clinical data, other scientific data and unmet needs

  • Overcoming obstacles such as clinical hold, health authority feedback, clinical study findings

  • Health authority (e.g., FDA, CHMP) meeting strategies, plans, supporting materials, and meeting conduct; optimizing feedback and gaining alignment

  • Positioning clinical and scientific data, justifying the indication and benefit/risk, and identifying and overcoming gaps and weaknesses

  • FDA advisory committee preparation

  • Regulatory dossier preparation: strategy, writing, reviewing, editing (e.g., IND, BLA, NDA, MAA)

  • Strategic guidance and writing/editing responses to health authority questions

  • Labeling (e.g., USPI, SmPC)

  • Risk management strategies including REMS and RMPs

  • Assessment and justification for breakthrough designation, orphan drug designation, fast track designation, priority review, accelerated approval pathways

  • Positioning drug development assets for further investment, out-licensing or partnerships

  • Outsourcing strategies and virtual resourcing models

  • Drug development team leadership

  • Lifecycle management

  • Promotional review from a medical perspective

  • KOL development, publication planning, and advisory boards