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Regulatory Compliance

Patient safety is at the heart of all that we do at Smartway. This means not only meeting our regulatory obligations, but innovating beyond.

We use our deep knowledge and understanding of global markets and legal systems, alongside our resilient supply chain, to help you enable patients’ access to medicines.

Approved Globally

Since 1992, Smartway has been authorised and regulated by competent authorities throughout the globe for the various activities that it carries out, including GxP and other regulated activities. These approvals and licences are maintained by our experienced regulatory compliance team, and are subject to routine inspections by government agencies, medicines regulators, pharmacy boards, our external assurance partners and our stakeholders. Smartway have extensive knowledge of all relevant regulations and best practices in the jurisdictions that it operates, to ensure compliant delivery of its services and role in the supply chain.

Compliance Culture

At Smartway, we have been built on a clear commitment to patient safety and high ethical standards since establishment. This is why our regulatory compliance team makes up 10% of our global workforce and has direct access to our executive team. The team grows with Smartway, ensuring a quality foundation on all we do. The international compliance team, which is embedded into our global operations, includes experienced senior pharmacy professionals, quality/safety professionals and legal professionals, all taken from across the healthcare/pharma/biotech space. At a governance level, we have built a supportive ethical culture with an emphasis on ethical leadership, speak up mechanisms and monitoring.

Technology Innovation

To maintain effective oversight of our operations, Smartway has invested into technology and automation. This has helped Smartway automate both critical and routine processes, enabling robust regulatory compliance, improved efficiency and significant risk reduction. This innovation has led to regulators identifying current gold standard practices because of the direct positive impact on patient safety and supply chain integrity, together with a high level of interest on our technology pipeline.

Consistent Standards

Smartway is required to adhere to the strictest of requirements across all jurisdictions we operate in. Whilst we comply with all relevant local regulation, we also ensure that all our sites comply to the highest level of global regulation – adopting the best practices from across the globe and applying it to all our regulated activities. To do this, we have built our global quality system so that it is able to function across all our sites, accessible by our entire workforce. To maintain these standards, we have a rigid process of internal audit, assurance visits and governmental inspections. This consistency in our approach means that wherever our clients work with us, they can be assured of consistently high standards.

Knowledge & Expertise

Through years of industry experience, Smartway has developed an unrivalled knowledge and expertise of the legal, ethical and regulatory landscape relating to the supply of medicines, whether it be cross border international supply, the import/supply of unlicensed medicines or supply to the Aid Development or R&D markets. This deep knowledge and expertise is coupled with our clear commitment to regulatory compliance and patient safety, puts us ahead.

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