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Enhancing Compliance, Efficiency & Market Access in the Pharmaceutical Industry

Your Partner in Excellence and Innovation

PharmAlign Solutions 

Bridging knowledge gaps, enhancing operational excellence, and ensuring the highest quality standards in pharmaceutical and vaccine manufacturing.

How we can help

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Specialized expertise in GMP, regulatory compliance, and pharmacovigilance

End-to-end support from licensing to logistics

Proven leadership trusted by global pharmaceutical companies

Regulatory expertise (SAHPRA, WHO, PIC/S)

Cost efficiency and faster market access

Serving clients across continents

Global Markets 
Regulatory Services

Specialized regulatory knowledge

Trusted Partner

Long-term client relationships

Expert Team

Industry leading professionals

Our Global Reach

Based in South Africa, PharmAlign Solutions serves global markets with a special focus on PIC/S-regulated regions. Our expertise spans across international regulatory frameworks.

Our Key Services

Comprehensive solutions tailored to meet the unique needs of pharmaceutical companies at every stage of development.

Regulatory & Compliance Consulting

  • GMP/GxP compliance (WHO, PIC/S, SAHPRA)

  • Licensing, dossier submissions, and supplier audits

  • Regulatory strategy for market entry

Quality Management Systems

  • eQMS integration (Veeva, TrackWise Digital)

  • SOP development and CAPA management

  • Risk-based quality assurance

Pharmacovigilance & Risk Management

  • Adverse event reporting and signal detection

  • Compliance with FDA, EMA, and ICH guidelines

  • Training for stakeholders

Audit Readiness & GMP Compliance

  • Mock inspections for SAHPRA, WHO, and PIC/S audits

  • GMP certification assistance

  • Compliance gap analysis and remediation

Cold Chain & Logistics

  • Validated transportation/storage (GDP compliance)

  • Temperature monitoring systems

  • Packaging validation

State Tender & Licensing

  • Government tender assistance (NDoH, SAHPRA)

  • Post-Import Testing Exemption (PITE) support

  • Bidding consultancy 

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