Regulatory Services

Regulatory Services Offered

DLI Regulatory Team has a rich and vast experience of Technology transfer projects and can help to do technology transfer or dossier sale or DMF sale :

  • More than 10+ years of experience in product development for regions like USA, Europe & Mena.
  • Integrated services for new chemical entities, late phase product development and over-the-counter products with focus on quality, speed and cost-efficiency.
  • Clear and executable strategies for product development.
  • Dossier document preparation in CTD/ACTD format.
  • Compilation and review of dossier as per CTD/ACTD/Country Specific.
  • Guideline for East & West African, CIS, Latin & Asian Countries.
  • Legal Application – COPP, Product Permission, FSC etc.
  • Post approval query response till registration obtained.
  • Renewal / Retention Application.
  • Variation Application.
  • Import License.
  • Module 4 & 5 – Clinical & Non-Clinical Dossier.
  • Labelling / Artwork Preparation.
  • Drug Master File preparation.
  • Compilation of dossier as per latest eCTD guidelines for some countries / ANDA preparation.