Regulatory Affairs

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