MUMBAI, August 24, 2015 /PRNewswire/ —
Accutest Research Laboratories, a leading global Contract Research Organization (CRO), further pursues its strategic expansion into Latin America by opening offices and establishing operational presence in Brazil.
Market surveys clearly indicate that Brazil is one of the fastest growing pharmaceutical markets globally, with its huge population of more than 200 million, an investment friendly environment, an effective patent protection regime and a relatively low incidence of spurious drugs. The pharmaceutical market of Latin America’s largest economy is projected to reach sales of up to USD 46 billion by 2018, growing at a CAGR of 12%.
By establishing offices and operations in Brazil, Accutest participates and shapes the potential of the Latin American CRO market and contributes to the growth of its pharmaceutical sector.
Accutest continues to be at the forefront of global CROs, performing clinical and BA/BE studies for submissions in all key regulated markets. The company strictly pursues the highest quality standards and has been following in every detail regulatory principles over thousands of studies.
Of its strong regulatory track record of 80+ accreditations/approvals from global regulatory agencies, 12 are from ANVISA, the regulatory body that oversees the registration, production and sale of drugs in Brazil.
Speaking on the expansion, Founder and CEO Dr. Satish Sawant stated, “Opening offices in emerging countries to support drug development is a key element of our expansion strategy. We have identified seven emerging countries to develop operational capabilities, and by opening offices in Brazil, Malaysia and Taiwan we have completed our current expansion phase.”
“Our scientific competence, timely delivery, quality excellence and cost effectiveness have led Accutest to become one of the preferred CRO partners to pharmaceutical and biotechnology companies globally. Our dedicated regulatory team liaises with the regulators to ensure efficient management of approval processes, which has resulted in performing over 230 BA/BE studies for ANVISA submissions in Brazil alone until now,” said Dr. Ashutosh Pudage, President – Bioanalytical on Accutest’s accomplishments.
Superior quality, adherence to timelines and competitive costs are the three pillars of a successful CRO. During a preceding expansion phase, Accutest opened offices in the US and in the Netherlands. By adding emerging countries, especially in Latin America and in Asia, Accutest will gain additional benefits which will be passed on to its vast client base.
About Accutest Laboratories:
Accutest is a global independent and internationally accredited CRO offering services to customers around the globe. Accutest is the market leader amongst independent CROs, with the highest quality standards, quick turnaround times and a strong regulatory track record of 80+ accreditations/approvals from global regulatory agencies.
Its service offerings include:
1. Bioavailability/ Bioequivalence (BA/BE): Accutest Laboratories owns and runs fully-equipped, state-of-the-art infrastructure which include 9 clinical pharmacology units with a capacity of up to 346 beds and a diversified database of over 34,000 volunteers. The clinical laboratories are CAP and NABL accredited and bioanalytical laboratories complemented with a pool of 40 highly sensitive and latest generation LC-MS/MS instruments spread across the sites.
Accutest has successfully executed more than 2,200 BA/BE studies including most challenging ones from both, a clinical and analytical perspective. Accutest is a preferred partner of pharmaceutical companies across the world including USA, Europe, Brazil, South Africa, China, South East Asia, India and more.
2. Clinical Development Services (CDS): Accutest Laboratories has capabilities to execute Phase II to IV clinical trials in Asia and Latin America. Accutest offers end-to-end services for small molecules, big molecules and medical devices under CDS roof, which covers Clinical Operations, Clinical Data Management, Pharmacovigilance, and Medical Writing services. These services are offered as a standalone or as a bundled package.
3. Biologics and Biosimilars: Accutest Laboratories 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 1 and Phase 3) as well as bioanalytics for biopharmaceuticals; such as, pharmacokinetics, pharmacodynamics and immunogenicity assessments. Additionally, Accutest Laboratories 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.
SOURCE Accutest Research Laboratories (I) Pvt. Ltd.