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From the early product conception stage through to the design of the regulatory and clinical strategy and commercialization of your products in Europe, in the US and also on other markets Celetrax is ready to work with you to beat your internal targets and outperform your competitors.

Early stage Development

  • Product strategy
  • Regulatory Strategy
  • Gap Analysis and Costing
  • Agency Communication
  • CMC
  • Regulatory Writing and Submissions
  • Partner/ Technology Identification

Clinical
Trials

  • IMPD writing
  • Regulatory Strategy
  • Regulatory and Trial Design Consulting
  • Review of Protocol, Clinical Study Report to ICH/ GCP and Country-Specific Requirements

Late Stage Development

  • Product Strategy
  • Regulatory Strategy
  • Agency Communication
  • Clinical Study Design
  • CMC
  • Regulatory writing and dossier compilation
  • Submissions
  • License Holding (EU)

Reimburse-ment and market access

  • Market Analysis an Access Consulting
  • Pricing
  • Payer Strategy and Communications

Strategic Compliance

  • GxP Audits
  • Inspection Readiness
  • Quality Systems
  • FMD Consulting
  • Outsourcing Advisory, Third Party Audits

M&A, Strategic Partnering, Licensing

  • Product Due Diligence
  • Feasibility Assessment
  • M&A consulting (target identification, intelligence package compilation, etc.)
  • Product License Transfer