The healthcare industry in India has caught pace and is moving ahead with continuous developments. CROs are playing a major role in this and have witnessed a positive growth in the past few years. Through outsourced R&D services to the pharma, clinical device, and biotechnology companies, CROs bring in the promise of further developments in the healthcare space. From clinical research to product development, these companies provide the processes and services on contract basis. One of the leading companies contributing to the future of Indian healthcare industry through its comprehensive services is Accutest Research Laboratories (I) Pvt. Ltd.
Headquartered in Navi Mumbai, Accutest is a top-notch independent and internationally accredited India-based Contract Research Organization (CRO). Incepted in 1998, it offers best-in-class services along the whole drug development process to pharmaceutical, generics, and biotechnology companies. The company operates out of three facilities viz. Navi Mumbai, Ahmedabad, and Baroda. Accutest has emerged to be the undisputed leader in BABE segment for over two decades now.
The Sculptor of Accutest
Dr. Satish Sawant, the Founder and CEO of Accutest, is a very down to earth technocrat and a cricket enthusiast. He has completed his doctorate in analytical chemistry. He has spearheaded and shaped the incredible journey of Accutest as one of leading CROs in the industry through his sheer grit, farsighted business strategies, and zeal to consistently add value to research industry. His business acumen has rightly led him to exploit the huge demand in the market for BABE studies conduction as a mandatory regulatory requirement for the generic pharma manufacturers.
Dr. Sawant has been instrumental in manifold growth of Accutest by setting up a friendly and inclusive work culture, which does not compromise on quality while serving the clients with utmost integrity and efficiency.
Journeying to the Top
The idea of Accutest Research Laboratories was on the mind of Dr. Sawant since he completed his Ph. D in Pharmaceutical Sciences. After serving Indian pharma industry for about 15 years in the areas of drug research related to pharma testing using various modern chromatographic techniques, Dr Sawant set on a path to turn his long cherished dream into reality. In 1998, Accutest entered the industry as a small startup. Initially taking up small projects, the company gradually consolidated its position in the CRO industry.
When Accutest had started making its mark, there were not many USFDA accredited laboratories available to outsource clinical research requirements for pharma organisations. Pharma market was opening up and Indian Pharma Industry was gearing up to launch their products in developed countries like US and Europe. Thus, in 2004, the company got the approval from USFDA. After this initial step, there was no looking back whether it was to add new facilities, increase capacities or subsequent audits and approvals from prominent regulatory bodies across the world.
Under steady leadership of Dr Sawant, Accutest kept on innovating itself by adding range of diverse services. Accutest and its leadership have consistently been recognized for its success and constant good work with prestigious awards and accolades throughout its journey of 21 years so far.
Accutest provides services across various verticals like Bioavailability/Bioequivalence (BA/BE) studies for Generic Industry, Clinical Development Services (CDS) for New Chemical Entities, and Bio-analytical Services to Biologics/Bio-similar drug molecules. Speaking about all that they offer to the clients, Dr. Sawant says, “At Accutest, we assist Pharma industries in their drug development life cycle by evaluating its safety, efficacy, ADME character, and quality aspect before the product is certified as appropriate for marketing. As a CRO, we become a part of the pharmaceutical organizations in their research program to evaluate medicines for their quality and test on human population for the safety, effectiveness, and blood levels of the drug after they are consumed.”
Accutest has undoubtedly emerged to be the preferred CRO for first-to-file studies. The company also focuses on Phase II-IV clinical trials services for drug development companies in India and abroad. It conducts clinical trials as per Standard Operating Procedures (SOPs) developed in-house, in accordance with ICH GCP guidelines and Indian GCP to accomplish and efficiently cater to requirements of its clients.
Accutest Biologics, its subsidiary, is a one-stop solution for analytical and bio-analytical services from early stage characterization to the late stage clinical evaluation of biologics. Bioanalytical services include Pharmacokinetics, Pharmacodynamics, and Immunogenicity assessment of biologics, bio-therapeutics, biosimilars, vaccines, and non-biological complex drugs using high-end assay formats like ELISA, MSD, and GYROS. It also provides in vitro activity/potency and bioassays services for evaluating the biological activities besides toxic kinetics and related services.
What sets It Apart?
Being in clinical research field for 21 years now, Accutest is setting a niche in the industry with its unmatched expertise and services. The success stories of Accutest and accreditations from global regulators, like US FDA, WHO, EMA, ANVISA, DCGI, MCC and other prominent authorities, stand as a testament to its unwavering commitment to international quality standards and operating procedures. Recently, the company received the prestigious OECD GLP certification by NGCMA. Accutest is the first and only independent biologics testing facility in India to be honored with this international accreditation. The company constantly strives to reinvent itself, along with providing advanced services to its clients.
Accutest takes great pride in its dynamic team, which understands customer requirements and gives optimal solutions. Dr. Sawant asserts, “We have a rich pool of well qualified and dedicated professionals, these are our assets. Their rich experience and involvement during clients’ drug development program gives clients the confidence to outsource their clinical development needs. Timely delivery, our regulatory history, global reach, staff and our ability to work hand-in-hand with the clients are some of our value propositions which set us apart from other competitors in the market.”
Perfect R&D Partner
Accutest is the partner of choice for generic drug manufacturers looking to execute BA/BE studies with a high degree of quality and speed, at competitive prices. It has one of the largest data banks of 41,000+ volunteers along with strong regulatory track records. The company’s state-of-the-art infrastructure comprises of more than 400 beds, 38 LCMS-MS, and 700+ validated methods, enabling it to serve the clients with ease and quality. Acutest is rendering numerous benefits to its clients by catering to their complete, complex, and cross functional service requirements, under one roof with ease and expertise.