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Why Accutest?

•Global CRO
 Comprehensive drug development and testing services
•Drug development and testing for chemical and biological molecules
 Partner to generic and innovator companies
•Since inception 15 years consistent track global record
 Leveraging infrastructure, equipment and experienced team through all
 challenges including FTF in the US
•International quality standards
 US FDA, WHO, EMA, ANVISA Brazil
•Competitive pricing
 Delivery capabilities focused on key emerging markets
•Truly Independent
 No stake or partnership with any pharmaceutical company

About Us

Accutest is a global independent and internationally accredited Contract Research Organisation ("CRO") founded in 1998. We are offering services to customers around the world with operations in India, Brazil and Mexico. Accutest is the market leader amongst independent CROs, with the highest quality standards and quick turnaround time. We have strong regulatory track record and numerous accreditations/approvals from global regulatory agencies.

Vision

Global best-in-class Contract Research Organization offering comprehensive services along the whole drug development process to Pharmaceutical, Generics and Bio-Technology companies

Mission

Become the preferred CRO partner to pharmaceutical and bio-technology companies globally, by means of recognition, scientific competence, professional approach, timely delivery, cost effectiveness and quality excellence.

Values

Contribute to the well-being of humanity by being a partner in the drug development process, along with pharmaceutical companies.

Leadership Team

Our Services


We provide GLP and GCLP compliant Bio-analytical and immunogenicity testing services for biologics and biosimilars, commonly referred to as Bio-therapeutics, such as cytokines, chemokines, enzymes, fusion proteins, monoclonal antibodies and vaccines. Our expertise covers cell biology, immunology, molecular biology and biochemistry for tackling complex projects, pertaining to Bio-analytical testing and immunogenicity testing of biologics/biosimilars in an innovative and timely manner. In addition we provide a wide array of services that helps and complements the needs of our clients. With the extent of our scientific knowledge, our client communication skills, our commitment and our flexibility we provide a best-in-class “bench to bedside” solution for preclinical development of therapeutic bio-molecules. Our expertise includes design, coordination and execution of a variety of PK/PD, BA/BE, immunogenicity, immunotoxicity studies to support clinical testing of biologics/biosimilars.

Our Services Include:

· Custom assay design, method development, validation and    transfer - to test APIs, new biologics and generic biologics

· Biological Activity (Activity/Potency Assays), In vitro and In    vivo bioassays

· Immunogenicity testing : Multi-tiered approach

· Anti-Drug Antibody (ADA) Testing

•                Binding Antibody Testing (Screening and confirmation)

•                Enzyme-Linked Immunosorbent Assay (ELISA)

•                Standard sandwich ELISA

•                Bridging ELISA

•                Surface Plasmon Resonance (SPR; BioRad ProteOn                  XPR36)

· Neutralizing Antibody (NAb) Testing with Blocking Assays

•                Related to mechanism of action of biologics

•                Receptor Binding

•                Cell based functional assays

· Immunotoxicity (Pre-clinical testing)

· Biochemical Characteristics of Biologics

· Size, concentration, pH and Osmolarity

· Identity - (N-terminal, C-terminal, peptide mapping,    immunoblots, bioassays)

· Purity (1D/2D SDS-PAGE, HPLC, immunoblot, DNA, endotoxin,)

· Physiochemical integrity – Biologics

· Impurities from aggregates and degraded products

· Post-translational modifications (glycosylation, acylation,   phosphorylation, etc)

· Stability studies
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years consistent track global record

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and more BA/BE studies successfully performed

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employees

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ANDA files using our services

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Regulatory Inspections / Approvals (times)

International Addresses

GLOBAL

Accutest Research Laboratories Baarerstrasse 14
6300 Zug
Switzerland
Email:global@accutestglobal.com

USA

Accutest Research Laboratories INC 103 Carnegie Center Drive
Suite 300
Princeton, New Jersey - 08540
USA

Brazil

Accutest Research Laboratories Rua Cassiano Ricardo,
483 – CEP. 04640.020
São Paulo
Brazil

India

Accutest Research Laboratories (I) Pvt. Ltd
A-31, Khairne MIDC
TTC Industrial Area
Thane Belapur Road
400 709 Navi Mumbai
India

Mexico

Accutest Research Laboratories Mexico S.A. de C.V. Andres Teran 1125,
Colonia Chapultepec Country,
Código postal- 44620
Guadalajara, Jalisco
México

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