Market Access & Product Registration

Beyond pharmaceutical trading, Sky Pharma FZE delivers end-to-end services that ensure quality, compliance, and efficiency—from sourcing and regulatory documentation to logistics and market access.

Launching a pharmaceutical product in a new market requires more than supply—it demands regulatory navigation, dossier preparation, and local market insight.

At Sky Pharma FZE, we support clients with tailored market access and product registration services, ensuring faster approvals and successful participation in government and institutional tenders.

Our Services

Market Access Solutions We Provide

Dossier Preparation & Localization:

CTD/eCTD submissions, translations, and market-specific adaptations.

Product Registration:

Submissions to EMA, MHRA, GCC, MENA, and African authorities.

Labeling & Artwork:

Market-compliant labeling, serialization, and packaging support.

Tender Support:

Preparation of technical and commercial packages for government tenders.

Regulatory Intelligence:

Monitoring of evolving guidelines in EU, UK, MENA, and global markets.

Post-Market Support:

Assistance with renewals, variations, and pharmacovigilance compliance.

Geographic Reach

Global Market Access Expertise

Our registration and market access services are tailored for both regulated and semi-regulated markets, including:

  • Europe & UK – EMA, MHRA, national authorities
  • MENA & GCC – UAE MOH, SFDA (Saudi Arabia), Egypt, Jordan, Morocco
  • Africa Sub-Saharan registrations, tender compliance
  • Asia & Emerging Markets – India, CIS, Southeast Asia

This ensures our clients can expand quickly, compliantly, and competitively.

Documentation & Compliance

Registration-Ready Documentation

Sky Pharma FZE ensures every product is delivered with the technical file needed for fast-track approvals. Depending on requirements, our package may include:

  • DMF/CEP references (for APIs)
  • CoAs and stability data
  • CTD/eCTD dossiers (for FDFs)
  • Bioequivalence (BE) study reports (if available)
  • GMP/GDP certificates
  • Packaging, labeling, and serialization records

Tender Support

Helping You Win Institutional & Government Tenders

We prepare complete technical and regulatory submissions for tenders in the EU, UK, MENA, and Africa. Our support ensures compliance with eligibility requirements and improves your competitiveness in public procurement.

Why Choose Sky Pharma for Market Access

What Sets Us Apart

Local Expertise

Knowledge of regional regulatory frameworks.

Faster Submissions

Ready-to-submit CTD/eCTD dossiers.

Tender-Ready

Complete documentation for institutional buyers.

Ongoing Support

Renewals, variations, and post-market compliance.

Expand Into New Markets With Sky Pharma FZE

From dossier preparation to tender support, we make market access simple, compliant, and efficient.

Contact Market Access Team