NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Emerging BioPharma

  • Non-clinical program evaluation and strategy planning
  • Clinical program evaluation, strategy planning, and study design
  • Regulatory strategies and optimal pathways for US, EU and Asia submissions
  • Evaluation of formulation and CMC issues
  • Evaluation and recommendations in complex scientific areas including toxicology, non-clinical and clinical pharmacology, pharmacokinetics, and biostatistics
  • Analysis of clinical and non-clinical safety data and design of safety studies
  • Advisory boards and virtual management team support
  • Interactions with regulatory agencies, including preparation of briefing documents, rehearsals and meeting attendance

International Pharma

  • US, EU and Asia regulatory guidance
  • Meeting preparation and support for interactions with US, EU and Asia regulatory agencies
  • Assistance in accessing US markets

Investment Organizations

  • Due diligence of acquisition opportunities with a focus on determining the current stage of development
  • Evaluation of product licensing opportunities
  • Supplemental management expertise and virtual management teams for early-stage companies
  • Analysis of unexpected clinical trial results in portfolio companies
  • Risk management across the product life-cycle
  • Advisory boards

Law Firms

  • Litigation support
  • Depositions and Expert witnesses
  • Expert reports and other background documents
  • Labeling requirements
  • Manufacturing compliance issues
  • Detection and analysis of safety signals
  • Intellectual property issues

Government

  • Product development and regulatory support for biomedical research and development programs
  • Advisory boards

Health Care Providers & Payors

  • Drug safety assessments
  • Comparative efficacy assessment
  • Assistance in addressing complex medical products issues
  • Advisory boards