Global Market Access Support Services

Global regulatory affairs strategy development and submissions

  • Global regulatory landscape assessment and analysis
  • Development and implementation of global regulatory strategies
  • Quantitative cost/benefit analyses and modeling for regulatory strategy alternatives, including associated expenses and projects from a market penetration perspective
  • Design and implementation of online and on-ground global regulatory training courses
  • Literature reviews to support regulatory submissions
  • Biologics License Application (BLA) submissions, including those related to biosimilar technologies
  • 510(k) premarket notification submissions, including potential predicate device identification
  • Investigational Device Exemption (IDE) submissions, including risk/benefit and technology/product safety assessments
  • Premarket Approval (PMA) submissions, including development of clinical evaluation plans
  • Submission of Food, Drug and Cosmetic Act Section 513(g) requests to FDA
  • Combination product submissions, including support for FDA’s Office of Combination Product (OCP) evaluations

Global reimbursement strategy development and submissions

  • Global reimbursement landscape assessment and analysis
  • Development and implementation of global reimbursement strategies
  • Design and implementation of online and on-ground reimbursement training courses
  • Literature reviews for reimbursement submissions
  • Dossier development and submission to Medicare and Medicare Administrative Contractors (MAC)
  • Dossier development and submission to US private payers
  • Dossier development and submission to international governmental agencies
  • in major markets, including NHS in the UK and the Federal Joint Committee (G-BA) in Germany
  • Dossier development and submission to emerging market governmental agencies including China and Brazil

Development of pricing strategies for global medical device, biologic and speciality pharmaceutical product commercialization

Some of our pricing analysis methodologies include the following analytic techniques:

  • Conjoint analysis
  • Gabor-Granger analysis
  • Van Westendorp analysis
  • Survey and in depth interview analysis

Development of health economics outcomes assessment and strategy

  • Development of payer value dossiers
  • Global cost and comparative effectiveness evaluations for new technologies and products
  • Development and implementation of global health and economic outcomes strategies
  • Design and implementation of online and on-ground training courses in cost and comparative study design and execution
  • Review and assessment of Health Technology Assessments (HTA’s) and their potential impact on technology and product commercialization
  • Incorporation of cost and comparative effectiveness and HTA study results into reimbursement dossiers