SERVICES
Regulatory Affairs
As a registered Scientific Office, we offer comprehensive Regulatory Affairs services to ensure full compliance with the Emirates Drug Establishment (EDE) in the UAE.
Our team of experts collaborates closely with local regulatory ministries and international partners to streamline registration and approval processes for healthcare products.
Our Services Include:
Site Registration Support: Comprehensive manufacturing site registration service with EDE.
Product Registration: End-to-end management of dossiers (CTD, eCTD) aligned with UAE regulatory requirements.
Regulatory Consultation: Customized compliance strategies based on product type.
Labeling & Artwork Review: Ensuring all packaging and inserts meet local regulatory requirements.
Regulatory Updates: Real-time monitoring and updates on regulatory changes to ensure ongoing compliance.
Renewals & Variations: Lifecycle management, including renewals and modifications to existing authorizations.
★★★★★
Marketing & Business Development
Our Services Include:
Market Access Strategy: Identifying regulatory pathways, pricing strategies, and competitive positioning for new products.
Product Launch & Brand Planning: End-to-end support for product introductions, including launch planning, promotional material development, and medical marketing.
Stakeholder Engagement: Building strong relationships with healthcare professionals, regulatory bodies, distributors, and key opinion leaders (KOLs).
Business Partner Identification: Facilitating connections with reliable local distributors, hospitals, and pharmacy chains.
Market Intelligence & Analysis: Providing actionable insights on market trends, competitor activity, and growth opportunities.
We help our partners expand their footprint in the region with strategic, compliant, and market-driven approaches.
★★★★★
Ready to give your products the green light?
Let us assist you in getting them registered!
Site Registration
Manufacturing site registration and renewal with the UAE Ministry of Health and Prevention.
Conventional Product Registration
Full dossier preparation, submission and follow-up for conventional pharmaceutical products.
GSL Product Registration
Registration of general sales list products for pharmacy and retail availability.
Dietary Supplements Registration
Compliance review, labelling and registration of supplements and nutraceuticals.
Medical Devices Registration
Classification, documentation and registration of medical devices for the UAE market.
Let’s Grow Together
Looking for a trusted partner for pharmaceutical, nutraceutical, or healthcare products in the UAE? Let’s discuss how SKY BIOTECH can support your market growth.