Health IT company RegDesk developed a network of regulatory compliance consultants across 140 countries to help life science companies navigate the path to market. Now it’s preparing to roll out a new product that would automate the process of renewing licenses for companies’ products in these countries.
In a phone interview with MedCity News, the CEO and founder of the DreamIt Health accelerator grad, Priya Bhutani, said it’s positioned to save companies a lot of time because its network offers a one stop shop for several countries for small and medium-sized biotech and medical device businesses. She sees her approach as more competitive, cost-effective, providing the most up to date information compared with what can be found on the pages of business intelligence reports report, and more comprehensive than any other one company’s resources.
When companies are working with a new country it’s not just about working through the regulatory requirements in each country. They also have to surmount language barriers, cultural differences and the local bureaucracy. Without regulatory approval, they can’t access those markets.
“Our goal is to reduce the anxiety and uncertainty associated with that process and empowering companies to have access to that knowledge,” Bhutani said.
The network has “hundreds” of consultants. “Each of them has an average of 15 years’ experience in regulatory compliance,” Bhutani said. “They have worked for a country’s ministry of health or have retired from large corporations and have worked with a country’s local authorities. They know the regulatory nuances.”
Companies pay a subscription service to access the network. Each country has several consultants, Butani said, and they offer their own rates for each project.
In addition to the network, the company is rolling out a new service by the end of the second quarter that automates the process of renewing product licenses in each country. It was developed in response to customer requests. Most companies have to do this manually or have an old, inefficient IT system, according to Bhutani.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
RegDesk obviously doesn’t mind a challenge since it’s setting itself to compete against contract research organizations that have been building these kind of support services for medical device and pharmaceutical companies for years. But if RegDesk is successful in executing global compliance support services that its customers want, their lean setup may be an asset against larger rivals.
