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Accutest Research Laboratories - Contract Research Organization

Accutest - a leading global independent and internationally accredited Contract Research Organization (CRO), offering services to customers around the world. Since its inception in 1998, the company has built an unmatched platform to provide end-to-end services to pharmaceutical and biotechnology companies globally. Accutest is the market leader amongst independent CROs, with the highest quality standards, quick turnaround time and global regulatory accreditations/approvals.

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Our service offerings:

arlBioavailability/Bioequivalence (BA/ BE)

Accutest is the partner of choice for all international pharmaceutical companies looking to execute BA/BE studies on various dosage forms at top quality, top speed and at competitive prices. Our 35,000+ sq ft fully equipped infrastructure includes 9 clinical pharmacology units with a capacity of 346 beds and a diversified database of over 34,000 volunteers.

The clinical laboratories are CAP & NABL accredited. This large infrastructure is complemented with a pool of 44 highly sensitive & latest LC-MS/MS instruments spread across sites in India.

ACCUTESTWe are a leader with an experience of conducting over 2,200 BA/ BE studies for pharmaceutical companies across the world including US, Europe, Brazil, China, India and more. Today, the company is one of the largest CRO in India with an estimated market share of 20% in the BA/BE space.

Clinical development services (CDS)

ARLClinical Trials are integral part of Drug Development. Accutest also executes clinical trials in Asia for submissions to all major regulatory authorities. In Phase II to IV clinical studies, Accutest offers end-to-end services for small molecules, big molecules and medical devices under CDS roof. It also covers Clinical Operations, Clinical Data Management,

Pharmacovigilance, and Medical Writing services. These services are offered as standalone or as a bundled package. Experienced project management team with effective planning has successfully completed numerous complex clinical trials across Asian region.

Biologics & Biosimilars:arl

Accutest delivers comparability solutions for biosimilars, novel biologics and non-biological complex generics. Comprehensive solutions can be provided for complete clinical comparability assessment for biosimilars with respect to both conducting the clinical operations (Phase I and Phase III) as well as bioanalytics for biopharmaceuticals; such as, pharmacokinetics, pharmacodynamics and immunogenicity assessments. Additionally, Accutest can also support on certain early stage molecular and functional characterizations such as N - and C - terminal sequence, glycosylation, disulfide linking, ADCC, CDC, Ligand Binding and other Potency assays.

ARLAlong with our comprehensive service offerings, we believe in absolute customer satisfaction and adherence to the highest standards of quality, which helps us in widening the database of loyal clients.

Global accreditations provide the stamp of approval for our quality systems. We have a consistent track record of 76 inspections/approvals from prominent global regulatory bodies like USFDA, ANVISA, WHO, EMA, DCGI, MCC, MOH-Turkey, NPCB-Malaysia and many more.

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As an endorsement to deliver the best Quality in Global CRO segment, Accutest has been awarded the "International Quality Summit Award in the GOLD category" by Business Initiative Directions, US based on customer voting. Similarly other International awards have distinguished Accutest in the field of Quality, Innovation and Excellence - "The Majestic Five Continents Award" as an entity, for corporate achievement, to recognize prestige, innovation and quality commitment, "India INC. 500 award" for being one of the fastest growing company, "The Inc India Innovative 100 award" in recognition of smart innovation and ingenuity.

Accutest is a true end-to-end solution provider in the market with our mission "to become the preferred CRO partner to pharmaceutical and biotechnology companies globally, by means of scientific competence, timely delivery, cost effectiveness and recognition".

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Accutest Research Laboratories
A-31, Khairne MIDC TTC Industrial Area
Khairne, Navi Mumbai, 400 709. India
Phone: +91-22-2778 0718/19/21

Accutest Research Laboratories
Baarerstrasse 14
6300 Zug
Switzerland

business@accutestglobal.com
www.accutestglobal.com