Contract Research & Development

More than 10+ years of experience in product development for regions like USA, Europe & China and 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.

Evaluation and Recommendations of API and Drug Product for IP landscape across the globe.
Product, process, method of use patent for USA, Canada, EU and ANZ markets.
Formulation patents.
Polymorph selection.
Patent opinion.
Litigation advise and identifying right legal attorney for different markets.