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.