Technical Project Management

Technical Project Management

Abba Pharma Limited project managers in the last decade have supported a number of projects with cross functional abilities including technical, scientific, medical & commercial projects in the clinical & CMC segments.

• Integrated CMC
  • Preapproval regulatory support during development
  • Due diligence and audits (companies, submissions, sites)
  • Post approval assessment of manufacturing changes and process / product deviations; stability updates
  • Annual product reviews
• Clinical / Non Clinical
  • GCP / GLP Auditing
  • Clinical Expert Report
  • Review of Study design and protocol
  • Compilation of clinical sections for dossiers