SWAPNIL SHELAR's Contact Details

SWAPNIL SHELAR's Company Details

Accutest, a global independent and internationally accredited Contract Research Organisation (“CRO”), with more than 20 years of experience and over 700+ employees in supporting the end-to-end services for global bio-pharmaceutical, biotech, medical device, nutraceutical and FMCG companies. Accutest is the market leader among independent CROs, with the highest quality standards and quick turnaround times. We have a strong regulatory track record and numerous accreditation/approvals from global regulatory agencies. We offer services in 3 verticals: 1. Bio-availability and Bio-equivalence studies (BA/BE) - 2. Clinical Development Services (CDS)- Phase II - IV studies, Post marketing, Investigator initiated & stand alone services (medical writing, regulatory consultancy, clinical data management) 3. Biologics Services - Solutions for biosimilars, novel biologics and non-biological complex generics Successfully cleared below inspections: USFDA – 33 times (latest Nov, 2018) WHO – 23 times (latest Jan, 2019) DCGI- 20 times (latest Oct, 2016) EMA – 8 times (latest Dec, 2017)