Regulatory Affairs Services

  • New product submissions (Rx, OTC, Complimentary Medicine, Generic, Biosimilar)
  • Dossier Evaluation and gap analysis
  • Variation and Changed Medicine Notifications
  • Full audits of regulatory files to ensure compliance
  • Promotional material review
  • Rescheduling and Reclassification submissions
  • Technical product support and advice
  • Prescribing Information, Data Sheets and Succint Statements
  • Labeling / artwork preparation and review
  • Fast Track and Orphan drug submissions
  • Development of GSASA data sheets