Product Development Consultancy

PharmaConsult can design a strategic solution that is tailored to your needs and development goals. Having led many successful projects with multiple regulatory agencies around the world, PharmaConsult can leverage years of professional experience to help move theory into action. We can provide you with the following services from the initial idea and incubation stage through new product approval (or market authorization) and have provided post-market analysis.

  • Authority Communication
  • Branding
  • Clinical Trial designs & study set-up
  • Clinical Trial Monitoring
  • CMC and Medical Writing for Development
  • CMC and Medical Writing for Submission
  • CRO Assessment & Selection
  • Development CMC / QBD
  • Development Strategy & Gap Analysis
  • Discovery Chemistry / Biology
  • Global Regulatory Strategy
  • Health Economics & Outcomes Research (HEOR)
  • IND/ IMPD Compilation and Submission
  • Labelling/PI/CCDs Management Globally
  • Market Research / Assessment / Value Inflection Points
  • Marketing / Labelling Activities
  • Medical Affairs (incl. information services)
  • Non-clinical studies
  • Preparation for Regulatory Bodies
  • Pricing & Reimbursement
  • Protocol Development & Review (Phases I – IV)
  • Regulatory Authoring (including QA & Review)
  • Rx to OTC Switch
  • Scientific Advice / Pre-Submission Meetings
  • Scientific and Medical Writing
  • Scientific Due Diligence
  • Statistical Services / Clinical
  • Statistical Services / non-clinical
  • Study Management & Selection
  • Technical CMC / Medical Writing & Dossier Updates
  • Technical Support for CMC / Quality