Regulatory & Documentation Services

Sky Pharma FZE provides comprehensive regulatory support—including DMFs, CEPs, CoAs, and technical dossiers—ensuring smooth approvals and compliance in regulated markets worldwide.

In highly regulated pharmaceutical markets, documentation is as important as the product itself. Sky Pharma FZE ensures that every API, excipient, or finished dosage form we supply is supported by complete, accurate, and up-to-date regulatory documentation.

Our regulatory services are designed to accelerate approvals, simplify audits, and provide confidence in every transaction.

Core Regulatory Services

Our Regulatory Support Includes

We don’t just find suppliers—we build partnerships that ensure stability and trust. Our approach includes:

Drug Master Files (DMFs):

DMFs for APIs, excipients, and intermediates filed in EU, US, and global markets.

Certificates of Suitability (CEPs):

CEP-backed APIs to streamline submissions in Europe.

Certificates of Analysis (CoAs):

Batch-specific quality documentation for every delivery.

Common Technical Documents (CTD/eCTD):

Complete dossier preparation for product registrations.

Regulatory Filings:

Support for variations, renewals, and authority queries.

Audit Support:

Supplier GMP certificates, site audit reports, and CAPA documentation.

Why Documentation Matters

Built-In Compliance for Market Entry

Pharmaceutical companies face increasing scrutiny from authorities such as the EMA, MHRA, US FDA, and WHO. Missing or incomplete documentation can delay approvals, impact tenders, or block product launches.

By partnering with Sky Pharma FZE, you ensure that every product is delivered with the required technical package—saving time, reducing risk, and protecting your market strategy.

Markets We Support

Global Regulatory Experience

Our regulatory expertise spans both regulated and semi-regulated markets, including:

  • Europe (EMA, national authorities)
  • United Kingdom (MHRA)
  • United States (FDA)
  • Middle East & North Africa (SFDA, Egypt, UAE MOH, etc.)
  • Asia & Africa (ANVISA, CDSCO, TGA, WHO PQ)

We adapt documentation packages to meet the specific requirements of each market, ensuring smooth registration processes.

Example Documentation Package

Typical Technical File Delivered with Each API

Sample List:

  • Certificate of Analysis (CoA)
  • CEP and/or DMF references
  • Stability data (real-time & accelerated)
  • Impurity profile and residual solvent reports
  • TSE/BSE statements
  • Elemental impurities (ICH Q3D) data
  • GMP & GDP compliance certificates

Note: Some documents are provided under NDA depending on product and manufacturer.

Why Choose Sky Pharma for Regulatory Support

Why Work With Our Regulatory Team?

  • End-to-End Compliance – From CoAs to full CTD dossiers.
  • Global Expertise – EMA, MHRA, FDA, WHO, and beyond.
  • Audit-Ready – Complete documentation to satisfy inspections.
  • Dedicated Team– Regulatory experts available for direct support.
  • End-to-End Compliance – From CoAs to full CTD dossiers.
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Ensure Smooth Approvals with Sky Pharma Regulatory Services

Let our team provide the DMFs, CEPs, CoAs, and dossiers you need for successful market entry.

Contact Our Regulatory Team