Piramal Clinical Research (formerly known as Wellquest Clinical Research) has capabilities for conducting bioavailability and bioequivalence studies, bioanalytical method development and validation, sample processing and analysis, statistical analysis and reporting, as well as facilities for sample and document storage in accordance with applicable regulations and sponsor requirements.

Bioavailability / Bioequivalence studies

Piramal Clinical Research offers the complete range of BA/BE studies

  • Bioavailability
  • Bioequivalence
  • Pharmacokinetic
  • Steady State Studies
  • Food Effect Studies
  • Single and Multiple Dose Studies

Our services include:

  • Study Design
  • Protocol Preparation
  • Subject Selection
  • Pharmacokinetic Evaluation
  • Statistical Data Evaluation
  • Study Result Reporting
  • Quality Assurance
  • Document Archival

Piramal Clinical Research has been involved in more than 100 pivotal bioequivalence and pharmacokinetic studies. Most of these studies have been carried out for international regulatory submissions including:

  • USFDA
  • UKMHRA
  • European Union
  • MCC-South Africa
  • Thailand FDA

Our clients have received product approval for generics in US and EU for which the biostudies were done at Piramal Clinical Research.

Bioanalytical Studies

Piramal Clinical Research provides bioanalytical services for bioequivalence studies as well as for new chemical entities (Phase I-III). The bioanalytical team at Piramal Clinical Research has developed and validated over 125 bioanalytical methods.
Bioanalytical Services:

  • Method development and validation
  • Bioanalysis for generic drugs (BE studies)
  • Bioanalysis for NCEs (Phase I-III studies)
  • Sample storage

Facility

Facility

Piramal Clinical Research has a state-of-the-art facility spread over 30, 000 sq ft at Hyderabad, India...

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