Regulatory Assistance
Expert dossier preparation and regulatory support for product registration across global markets.
Regulatory Assistance
Developing regulatory dossiers is a critical aspect of gaining approval or clearance for products in any territory. Nabiqasim, due to its vast experience and team of highly learned and competent regulatory professionals and experts, assists its customers with the suitable dossier required on the prescribed format for the territory they intend to market their products. CTD, eCTD & ACTD are a few examples in this regard.
Dossier Formats
CTD
Common Technical Document
ICH harmonized format accepted by regulatory authorities in major pharmaceutical markets worldwide.
eCTD
Electronic CTD
Digital submission format required by FDA, EMA, and other leading regulatory bodies for efficient review.
ACTD
ASEAN Common Technical Dossier
Regional format specifically designed for ASEAN member state regulatory submissions.
Why Choose Our Regulatory Team
Experienced Professionals
Highly learned regulatory experts with deep knowledge of global submission requirements.
Multi-territory Expertise
Experience across Middle East, Africa, Central Asia, and other key pharmaceutical markets.
Compliance Focused
Meticulous attention to format, content, and submission standards for each territory.