Additional Specialised Services
Explore our complete range of pharmaceutical compliance and regulatory solutions
PITE APPLICATION SUPPORT
Before the shipment lands.
Build the case.
Your supply plans depend on more than a shipment arriving. A Post-Importation Testing Exemption application needs a scientifically justified case, backed by clear, credible evidence.
PharmAlign Solutions supports medicine importers from eligibility reviews and gap assessments through Product Quality Portfolio compilation, scientific motivation and submission support. We connect manufacturer and GMP evidence, product quality history, stability and transport records into a coherent application, and support responses to SAHPRA queries. You gain a clear application strategy and experienced support at every step.
✓ Eligibility & strategy ✓ Evidence & dossiers ✓ Submission support
PITE application support · 40 seconds
Cold Chain & Logistics Solutions
We ensure the integrity of temperature-sensitive pharmaceutical products throughout the supply chain, from manufacturing to patient delivery.
Validated transport of APIs, finished products, and temperature-sensitive materials
Supply chain risk assessments and compliance
Warehousing and validated packaging solutions
GDP Compliance
Our cold chain solutions ensure compliance with Good Distribution Practice (GDP) requirements while optimizing logistics costs.
Post-Importation Testing Exemption (PITE) Consulting
Our specialized PITE consulting services help pharmaceutical importers reduce costs and accelerate market access by obtaining testing exemptions.
PITE applications and dossier preparation
Regulatory strategy to reduce import testing costs
SAHPRA compliance and exemption approvals
Featured: Post Importation Testing and Examination
Our expertise in post importation testing and examination requirements can significantly reduce your regulatory burden and accelerate time-to-market.
Procurement & Supplier Management
Our procurement services help pharmaceutical companies source high-quality materials while ensuring regulatory compliance throughout the supply chain.
Pharmaceutical product sourcing and contract negotiations
Packaging and validated shipping material supply
Supplier qualification and regulatory compliance
Supply Chain Excellence
Our procurement strategies balance quality, compliance, and cost-effectiveness to optimize your pharmaceutical supply chain.
