Adopting a customer-centric approach to deliver reliable, cost-effective, and valuable services at every point of interaction is the key attribute of ACUTA, a pharmaceutical and life science service and software provider. Incorporated by industry veterans in 2012, this Massachusetts-based company focuses on four strategic lines of business including integrated regulatory solutions, business process consulting, cloud-based solutions, and submission outsourcing. “The key indicator of ACUTA’s success has been customer relationships: although the company is relatively young, the key personnel have deep business and technical knowledge, with experience both as vendors and pharmaceutical customers,” says Shylendra Kumar, Founder and CEO, ACUTA.

The massive tech transformation around the world has also prompted life sciences and pharmaceuticals industry to incorporate cutting-edge technologies to automate their business functions. In order to help its clients keep the pace with the ever-changing business environment, the company has brought forth ARIM—a cloud-based solution which helps them manage the documents and datasets that define their products in realtime. The cloud hosting option of ARIM eliminates the concerns associated with installing and maintaining the software in-house and saves resources and time for ACUTA’s customers. “By providing a solution which can be configured in the cloud (or installed on premise), customers have the opportunity to maximize their IT infrastructure value,” adds Kumar. From managing investigational information through the post-approval process, and from submission planning to the registration of an approved product, ACUTA ARIM modules help its clients coordinate all operations and attain a competitive edge in the market.

By proffering the industry’s best of breed services to the life sciences and related industries, the company has steadily grown into a global business within a short time frame, powering innovations for its clients across various countries. As an established company in this sector, the company arms its clients with ACUTA PDF tools that are designed to optimize the processes of documents to meet agency and ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) regulations and guidance. “The PDF tools comprise various ‘Wizards’ that help companies automate the creation of the bookmarks and hypertext links required by the regulatory agencies, and to swiftly and clearly present an audit of the PDF documents’ readiness for submission,” explains Kumar. This not only includes the links and bookmarks but also ensures the consistency of page layout, and whether the text is a scanned image or searchable.

With its customer-centric approach to Regulatory Information Management, ACUTA bestows its clients with a set of tools for both the regulatory operations side (submissions for investigational and marketing approvals) and the regulatory affairs side (commitment tracking and registration tracking).“The reporting and tracking capabilities of the various modules in ARIM permit companies to better manage their commitments to agencies for completion of studies, to stay ahead of annual filings, and to optimize resources needed to keep those obligations on time and under budget,” explains Kumar. While the ACUTA PDF tools provide document-level validation of compliance with regulatory standards, the Publishing, coupled with the Planning, Validation and viewing capabilities of ARIM, gives customers comprehensive reports of every aspect of regulatory submissions. This enables its clients to significantly reduce the chances of receiving a Refuse-to-File or rejection from the agencies. Kumar further adds, “The validation criteria are based on the published validation rules from each region and ACUTA best practices.” These validation reports are available for the requirements of various countries including United States, Switzerland, Australia, Canada, Japan, the Gulf Coast Consortium, and South Africa.

Recently, a Boston-area based small biotech company approached ACUTA for an Investigational New Drug (IND) application. Backed by a team of proficient strategists and industry experts, ACUTA delivered the application and enabled the company to meet their business goals ahead of the project deadline. Customer quote:
“Thank you Shy, it has been a pleasure working with you and the rest of the ACUTA team. We appreciate all of your hard work to allow us to submit our IND a full two days ahead of schedule. This is a large milestone for us and ACUTA has played a pivotal role in ensuring we met our milestone.”

ACUTA’s primary customers are the small-to-mid-size companies that are often ignored by some of our larger competitors

In another instance, the company implemented ARIM at a Massachusetts-based customer for a subsidiary and empowered the customer to go operational within one month, giving the training and validation in real-time. The evolution of ACUTA from startup to a global business within a short time frame is a testament to its success. “ACUTA’s primary customers are the small-to-mid-size companies that are often ignored by some of our larger competitors. The multitenant cloud abilities of ARIM and ACUTA Validator allow those companies to avoid IT costs for servers and software maintenance and get up and running quickly,” delineates Kumar.

Propelling clients forward by offering innovative solutions including support for the upcoming IDMP (Identification of Medicinal Products) ISO standard requirements in Europe, and helping companies of all sizes with management regulatory services are on the top of ACUTA’s charted roadmap. In terms of geographical expansion, the company intends to open a new office in UK. This will further help its clients in Europe and elsewhere by providing the last missing piece of around-the-clock services, and local support for European operations.