Regulatory Compliance

As part of our regulatory commitment, all senior managers are given specialist training so that they can carry out their roles and continue to drive a positive compliance culture. The regulatory team have a direct reporting line into the board, so that decisions can be made without delay.

At Smartway, frequent training, development and reinforcement takes place for all of our staff, regardless of where they are in the world. But, we go further by building a strong compliance culture, enabling colleagues to be candid about learning experiences and improvement opportunities. We regularly solicit feedback from staff (including anonymously) to improve the effectiveness of our operations.

We have a robust set of procedures and clear expectations about what is expected of our staff, wherever they are in the world. This includes procedures relating to anti bribery and corruption, modern slavery and whistleblowing.

To ensure we only work with organisations that share our ethical values, we carry out audits and assessments of potential partners to ensure that they are clearly aligned to our commitments. Where they fall short, Smartway will take robust action against that partner.

Smartway has its own dedicated team of software, system and application developers who are able to work with our teams and sites to enhance our regulatory and operational capabilities. These changes are overseen by our senior regulatory colleagues, who carry out extensive validation to check the effectiveness of our systems. This has helped in the past build custom software to assist customers, suppliers and regulators.

As part of our investment in technology, Smartway has built its own proprietary IT systems to aid the due diligence processes on customers and suppliers, traceability of medicines down to individual packs and intelligence led alerts for supply chain risks (including temperature, adverse media and logistics).

We use state of the art technology to manage our quality, safety and general operations. Our eQMS is deployed across all of our global sites. It maintains our central risk register, internal and external audits and quality/compliance investigations. By design, eQMS maintains contemporaneous records and upholds rigid document control, data collection and safety records, whilst encouraging continuous improvement. As part of our systems, all of our senior regulatory colleagues and senior managers are notified in real-time of any feedback or issues raised so they can be handled with the appropriate level of oversight.

Our quality system adheres to the strictest regimes, with work instructions and manuals expanding on procedures to ensure our team always understand how to maintain the high standards expected of them. Additionally, each site is managed by local specialists, but overseen by our global headquarters in London. Regular meetings take place between departments and sites which ensures continuity of supply, service and quality no matter where in the world we are distributing. This regular communication across the globe leads to the identification of learning and improvement opportunities, taking best practice and applying that to our operations.

In order to meet our commitments, we are subject to regular scrutiny of our systems to ensure that they are effective. This includes inspections by regulatory authorities and governments, through to internal audits carried out by our team or external audits commissioned by us. We take these findings seriously and put in actions to improve the effectiveness of our quality systems.

Conducting international distribution since 1994, we have had decades to grow our knowledge and expertise in the pharmaceutical space.

We have invested significantly in a best-in-class regulatory team drawn from across the healthcare, pharmaceutical and legal space, from manufacturing to grassroots dispensing to patients. We have experience from both ends of the supply chain.

Our team includes experienced pharmacists who have managed large and complex operations in the National Health Service, through to senior regulatory experts drawn from across the globe. The strength of our team means that we have superior knowledge and expertise in the procurement and distribution of pharmaceuticals across the globe. Each senior officer holder appointment to our regulatory team is approved by the regulator, for added confidence.

We invest in professional memberships for individuals within the team to ensure their continued competence and to promote knowledge sharing with the wider team. We invest continuously in training and attend regular events, including private events run by regulators across the globe to learn and share best practice.

Using the experience of our team, we maintain our own proprietary and bespoke databases including a comprehensive set of domestic regulations, country requirements and logistical nuances across all of the continents, which we regularly update with new information to ensure we stay ahead in the procurement and supply of pharmaceuticals.