Accutest is a global independent and internationally accredited
Contract Research Organization (CRO) founded in 1998. Accutest offers services
to innovator and generics companies around the world and is the market leader
amongst independent CROs with highest quality standards and quick turnaround
times. Headquartered in Navi Mumbai, India
offering comprehensive drug development services in 3 verticals:
1. Bioavailability /Bioequivalence: ACCUTEST is the undisputed leader with an experience
of conducting more than 2500 BA/ BE studies for pharmaceutical companies across the
world including USA, Europe, Brazil, China, India and more. Today, the company
is one of the largest independent CRO in India with the leading market share.
2. Clinical Development Services: Clinical
Trials are integral part of drug development. Accutest runs end-to-end services
for Phase II to IV clinical trials on small molecules, large molecules
and medical devices with fully ICH GCP, complied operations.
Accutest is one of the few CRO's providing end-to-end services (protocol
writing to CSR submissions) along with stand-alone customized services like
clinical data management, medical writing or biostatistics.
Services for Biologics and Biosimilars: Accutest Biologics is a state-of-the-art, GLP practicing
CRO offering analytical development services for discovery and development of
biologics at pharmaceutical and biotechnology industries worldwide. We provide
a one-stop solution for analytical services of biologics from early stage
characterization to the late stage clinical evaluation of biologics. We can
also provide a comprehensive comparative package for demonstrating the
comparability of a biosimilar product with that of the marketed innovator
product on the basis of both, the physico-chemical and biological
characteristics before the preclinical stages and the pre-clinical and clinical
comparability post the process development stages.
ACCUTEST is ‘One-stop-shop' for
end-to-end product development and clinical research. The company has built an unmatched platform to tap the global BA/BE
opportunities with GCP and GLP compliant facilities globally.
Global accreditation provide the stamp of approval for their
quality systems. Accutest has 100+
consistent track records of successful inspections from global regulatory
bodies like USFDA, WHO, EMA, DCGI, ANVISA, ISP-Chile, MCC, MOH-Turkey,
MOH-UAE, NPCB, Thai-FDA & many more.