Regulatory Affairs

  • Dossier GAP Analysis
  • Strategy of Regulatory Submission
  • Controlled Correspondence
  • Scientific & Medical Writing (Clinical & Non-clinical overview, Summaries)
  • Dossier/Technical Drafting
  • Dossier Publishing – eCTD &/or NeeS
  • Life cycle management
  • Artwork Management
  • Local US agent
  • Translation services
  • eCTD online training

Pharmacovigilance

  • End to end PV set-up (US/EU/ROW)
  • Services of EU QPPV, Local QPPV
  • Case searching, Processing, Reporting
  • Establishment of PSMF and RMP
  • Drafting – PSUR, PBRER, PADER, DSURs
  • Signal Management
  • SOPs
  • Literature Monitoring
  • Mobile Applications

Request A Free Consultation

To Get Free Advice On Your Requirements From Our Specialized Advisor

Call: +971 50 127 3405

Marketing Support

  • Finding local and regional distributor(s)
  • Market Access support

Pharmaceutical Procurements
Specialized in sourcing drugs for

  • Identifying NICHE products
  • Unmet health condition
  • Rare diseases
  • ARVs
  • Oncology
  • Difficult to find mechations
  • Orphan
  • Product list (will share later)