R&D Capabilities

More than 30+ 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.