‘Plug-and-play’ regtech solution enhances patient safety

With a focus on pharmaceutical supply chain regulation, Bonafi is one of the latest companies to launch within the burgeoning regtech startup sector.

"Companies operating in the global pharma industry must verify that those they are buying from and selling to are authorised to handle medicinal products for human use in their own countries," explains its founder, Katarina Antill. "At present, this verification process is manual. Companies are using screenshots as proof and relying on spreadsheets to track verification activities, which increases the risk of errors."

Bonafi’s cloud-based platform automates the verification process and allows pharma companies to verify customers and suppliers from a single point regardless of their location. Bonafi’s potential customers are global pharmaceutical manufacturers and wholesalers and it is just about to enter a beta trial with a full product launch in June. The aim is to have the platform live in three European markets by next year with the US to follow by 2025.

Swedish-born Antill comes from a legal background. She studied law at Uppsala University in Sweden and at Leiden University in the Netherlands and spent a decade in the aviation sector in the US before moving into the pharmaceutical industry where she worked in various leadership roles in Sweden, Germany and Ireland over a 10-year period. Having experienced various regulatory-related compliance headaches at first hand, Antill could see an opening for a one-stop-shop verification solution and she began working on the idea for what has since become Bonafi while completing her MBA at DCU business school.

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“Manual processes are very labour intensive not least because companies must deal with multiple registries across multiple countries,” she says. “Most pharma manufacturers and wholesalers don’t have the resources to reverify their trading partners more than once a year, which is the current minimum legal requirement, and this too creates a potential vulnerability that can ultimately have an impact on patient safety and increase corporate risk.

Between time and money, Antill estimates the company's startup costs to date at about €200,000

“I could see that this huge volume of manual work was a threat to patient-safety and extremely inefficient,” she adds. “Our solution gives companies much greater control over their compliance activities because they no longer have to rely on manual processes. It can also retrieve and aggregate data from multiple registers across multiple countries and has a constant monitoring and alert system, quality management dashboards, electronic signatures and workflows and will strengthen the attributes of traceability, transparency and security. It is all designed to help companies to be pro-active in their compliance activities, enabling them to go beyond compliance alone to reduce corporate risk and patient risk.”

Bonafi employs four people and is now looking to recruit five more to build out its team. Between time and money, Antill estimates the company's startup costs to date at about €200,000. The company has been supported by Enterprise Ireland under the competitive start fund and Antill has recently completed the New frontiers programme at the LINC innovation campus at Blanchardstown IT. The company is about to embark on a funding round to raise between €750,000 and €1 million to support its commercial launch and drive its aggressive sales targets.

‘It’s complex’

Bonafi is a SaaS model with tiered subscription-based pricing. However, Antill stresses that the service being provided goes well over and above standard SaaS offerings. “Because it’s pharma it’s complex so we offer a very personal onboarding, training and support service to our customers and we will work with them to streamline their internal processes to reduce time and risk,” she says.

“Our main competition is the status quo,” she adds. “The pharma industry is understandably risk averse and any software used for compliance activities must be validated to pharma standards, which takes both time and resources. This is what will make Bonafi appealing to the sector as we offer a fully validated ‘plug-and-play ‘solution.”