MUMBAI, May 13, 2015 /CNW/ - During the period April 6th to 8th 2015, Accutest successfully completed its 22nd USFDA inspection without receiving any form 483. Accutest is a leading global independent CRO with a track record of more than 2,200 studies and 76 inspections from all major regulatory bodies worldwide. This positions Accutest at the forefront of CROs performing clinical studies and bioequivalence and bioavailability studies for global submissions. Accutest runs the operations in emerging markets with a team of more than 700, all in-house equipments managed by tight SOPs and state-of-the-art processes. The company's focus on quality and timely delivery at competitive prices has long established Accutest as a successful partner and preferred vendor to the world's largest and fastest growing pharmaceutical companies.
Dr. Satish Sawant, Founder and CEO, said, "Our leadership is backed by top-notched credentials. The recently completed 22nd USFDA inspection is a significant regulatory milestone as now all sites of Accutest have been accredited by the USFDA. Our dedicated team manages all regulatory issues with the regulatory authorities and client expectations achieving faster approvals for all studies globally."
Its service offerings include:
1. Bioavailability/Bioequivalence (BA/BE): Accutest 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 complemented with a pool of 44 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 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.
3. Biologics and Biosimilars: 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 1 and Phase 3) 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.
SOURCE Accutest Research Laboratories (I) Pvt. Ltd.