We provide all kind of consulting services in Regulatory affairs for national and international markets.

• Preparation of Regulatory strategy for dossier submissions
• Dossier compilation for US, Canada, Europe, Australia, New Zealand and Emerging markets (Type: eCTD, CTD, ACTD or country specific)
• Dossier conversion to CTD/ACTD format.
• Regulatory gap assessment and mitigation
• Life cycle management
  a) Post approval changes (including site change)
  b) Re-registration/Annual updates
  c) Change Control Management
  d) Labelling updates
  e) Regulatory risk assessment
  f) Post approval regulatory commitment