India is Asia's fourth-largest medical device market and one of the world's top 20. The overall market is expected to be worth $50 billionby 2025. Owing to this, the country's regulatory environment for medical and IVD devices has been gradually reinforced, requiring manufacturers to invest more in regulatory affairs. However, there aren't enough experienced regulatory experts who can assist the medical device manufacturers with the regulatory formalities. As per a recent report published by the Regulatory Professionals Society (RAPS), there are only about 15% of professionals who have experience of 5 years and above of working in the medical device industry. This is where Alceon comes in.
“Our key strength lies in our people. All of them come from the healthcare background, are highly trained and regularly updated with the latest requirements. They are highly committed in going out of the way and providing solutions to customers. We also gain from the larger ecosystem of our parent company Eupraxia which provides us the talent and experience in aspects of data analysis and biostatistics,” says Atonu Dutta, CEO, Alceon.
A division of Eupraxia Centre for Clinical Excellence
Alceon's team consists of medical device industry veterans who have worked on a variety of devices including cardiac, orthopaedic, wound care, and general clinical usage. Their staff is led by a former Notified Body Lead Assessor, and the documents are examined independently by senior external consultants who have previously worked for regulatory bodies and medical device businesses. In addition, the company organizes training sessions at regular intervals to keep their employees updated with all the trends. According to Atonu Dutta, “We keep our employees trained through internal or external training and this is a continuous process. In fact, we have weekly two-hour training and experience exchange sessions to keep everyone updated on the requirements.”
Our key strength lies in our people. All of them come from the healthcare background, are highly trained and regularly updated with the latest requirements
One-stop solution
Health care regulation is a complicated process; hence there is a growing need among businesses to hire regulatory professionals who can provide them with multiple benefits. For example, a manufacturer might need advice on which tests to perform, which labs to select, how to set up the site infrastructure and also the routine services of dossier preparation. Also, clients look not just for regulatory solutions, but also technical solutions. Alceon has been able to prove its efficiency in this segment as well. The company maintains a team of both internal resources and external experts who can provide the required advisory to the customers. They maintain contact with Notified Bodies (for CE marking) as well as different labs, giving them an insight on the expectations of these entities while preparing the dossier or even applying for a quotation.
At present, Alceon provides regulatory services to both medical devices and in vitro diagnostic devices. Its services are provided both to mature, older companies as well as to start-ups operating out of an incubator environment. In the future, the company wants to explore new technology areas like SaMD, Additive Manufacturing and newer areas of IVD devices.
