Shylendra Kumar, President & CEO
ACUTA was established in 2012 with a mission to simplify the management of regulatory information and offer a cost-effective cloud-based solution to the life sciences industry. Under the leadership of Shylendra Kumar, Founder and CEO, a 20-year veteran supporting Life Sciences, ACUTA’s strengths provide a way for life sciences companies to answer the challenges of today’s regulatory environment.
To get a new drug from invention to market can take 12 years and cost millions of dollars. Just getting an existing drug approved for new uses can still take considerable time and money. Managing the ongoing interaction with regulatory agencies to get marketing approval, and to keep it compliant once approved, is critical in this process.
ACUTA saw an opportunity to reduce or eliminate several challenges for both enterprise-level pharmaceutical companies and smaller life science startups. “Larger companies have many functional departments with their own point solutions, but they have no interaction between these systems,” explains Shylendra Kumar. “Some small biotech startups may only have a few people—mainly scientists—and no IT department to deploy and manage solutions.”
ACUTA’s talented team of developers and domain experts developed ACUTA Regulatory Information Management (ARIM) as a fully integrated cloud-based system to help companies coordinate and manage their regulatory information, so they can get new drugs to market faster. Kumar explains, “From a business perspective, time is money. From a moral and ethical perspective, patients are often waiting for these drugs to be approved. Our goal with ARIM is to help the industry be more efficient overall and to get treatments to patients in a safe and timely manner.”
The system centralizes data to eliminate information silos and manage regulatory information and submissions for new drugs, biologics, and devices.
We work very closely
with our customers,
listen to them and try
to bring in features and
functionalities they need
on a day to day basis
This solution includes a Microsoft Azure cloud-based offering that companies of any size can begin using in a matter of hours, and that reduces complex and expensive IT infrastructure.
ACUTA’s roadmap includes a focus on IDMP—the IDentification of Medicinal Products. A huge ISO standards initiative, IDMP standardizes medicinal product registration data globally. Soon companies will be required to use IDMP to report to agencies every change to medicinal product registrations. Though IDMP requirements are not yet finalized, ACUTA is already integrating IDMP into customers’ processes.
Regulators require lengthy documents to be submitted in PDF format with links and bookmarks to simplify agency review. With accuracy being critical, manual preparation of each document could take several days. Using ACUTA PDF Tools, another solution available to customers, fully compliant PDF documents can be prepared in minutes.
ACUTA’s customer support teams— manned in India, U.S. and U.K.—ensure 24/7 support for the submission process. Importantly, it’s not just software support—it’s also the vital support for regulatory guidance and related business knowledge. According to Kumar, “We work very closely with our customers, listen to them and bring in features and functionalities they need on a day to day basis. We see happy users as the key to our success.”
An example of that happiness came from a customer in Cambridge, MA. They were approaching submission of their first drug, confident with their regulatory information, but lacking the capabilities to address the regulatory submission processes. The company hired ACUTA to support them and the drug was approved in less than six months. ACUTA helped them become self-sufficient and they remain a happy customer.
With major developments like this, “ACUTA is doubling in size every year,” says Kumar. “But we don’t have a single salesperson, our business is coming through word of mouth because there are so many happy customers,” Kumar signs off.