Piramal Clinical Research is a contract research organisation that specialises in bioequivalence and analytical studies. With a 30,000ft² state-of-the-art facility in Hyderabad, India, Piramal Clinical Research can conduct bioavailability and bioequivalence studies, bioanalytical method development and validation, sample processing and analysis, statistical analysis and reporting.
Piramal Clinical Research is managed by dedicated professionals with wide-ranging experience in clinical research. All operations are driven by GCP and GLP systems as well as applicable national and international regulations. We have over 150 SOPs for clinical, bioanalytical and QA operations and more than 125 validated methods.
We have been involved in more than 100 pivotal bioequivalence and pharmacokinetic studies with expertise in analytical work for new chemical entities (Phase I-III studies). Most of these studies have been carried out for international regulatory submissions, including US FDA, UK MHRA, European Union, MCC-South Africa, and Thailand FDA.
Piramal Clinical Research is authorised by the Drugs Controller General (India) and has been inspected by the US FDA and Department of Medical Sciences, Ministry of Public Health (Thailand). Our clients have received product approval for generics in the US and EU for which the biostudies were done at Piramal Clinical Research.