Quality & Compliance

Sky Pharma FZE is committed to the highest pharmaceutical standards. From GxP-compliant processes to supplier audits and Quality Management Systems, we ensure every product we deliver meets regulatory and customer requirements.

Quality is at the core of everything we do. In an industry where patient safety and regulatory compliance are paramount, Sky Pharma FZE provides robust quality assurance practices and compliance frameworks that align with international guidelines, including GMP, GDP, ISO, and ICH standards.

Our Quality & Compliance service gives clients confidence that every API, excipient, and finished dosage form is sourced, stored, and delivered with complete traceability.

Our Commitment

End-to-End Quality Assurance

Every stage of our supply chain is designed to ensure compliance and safety:

Good Manufacturing Practice (GMP):

Verified manufacturers with current GMP approvals.

Good Distribution Practice (GDP):

GDP-compliant handling, warehousing, and logistics.

Quality Management System (QMS):

Documented SOPs, CAPA handling, change control, and deviation management.

Product Quality Review (PQR):

Ongoing monitoring of suppliers and batches.

Audit Program:

Regular supplier audits with transparent reporting.

Supplier Audits

Supplier Qualification & Audits

We maintain a strict vendor qualification program to ensure our partners meet international regulatory requirements.

This includes:

  • Pre-qualification audits of all new suppliers
  • Regular GMP site inspections
  • Review of manufacturing and analytical documentation
  • CAPA follow-up and requalification processes

Our audits protect our clients from non-compliance risks and guarantee that every supplier meets our rigorous standards.

Regulatory Alignment

Compliant with Global Authorities

Our quality and compliance framework is aligned with the requirements of:

  • EMA (European Medicines Agency)
  • MHRA (UK Medicines and Healthcare products Regulatory Agency)
  • US FDA
  • WHO Prequalification
  • National authorities across MENA, Asia, and Africa

This ensures smooth inspections, approvals, and market entry for our clients.

Documentation & Transparency

Documentation That Builds Confidence

Each batch we supply is accompanied by complete documentation, which may include:

  • Certificate of Analysis (CoA)
  • GMP and GDP compliance certificates
  • Stability and impurity data
  • TSE/BSE statements and elemental impurities data
  • Audit summaries (upon request)
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Why Choose Sky Pharma for Quality & Compliance

Why Partner With Us?

Compliance First

GxP standards applied across sourcing and distribution.

Audit-Ready

Documentation and processes that satisfy regulators.

Risk Mitigation

Supplier qualification and continuous monitoring.

Patient Safety

Every action guided by the principle of protecting end-users.

Partner With a Supplier That Puts Quality First

Sky Pharma FZE ensures that every product meets global standards—backed by rigorous audits, compliance frameworks, and transparent documentation.

Speak to Our Quality Team