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BA/BE Services

| BA/BE Services

The bioavailability and bioequivalence centre is offering comprehensive range of services to the various leading Generic, Pharmaceutical and Biotech industries in line with the global regulatory requirements to support the needs of the clinical research during the product development stage for their regulatory submissions.

The centre is approved by DCGI and conducting the studies by implementing stringent GLP/GCP practices. Our team of experienced clinical pharmacokineticists offers unsurpassed innovation and expertise in conducting clinical PK/PD studies and capable of performing multiple studies simultaneously in quick turnaround time.

Our reputation, excellent quality, on time delivery, with personalized service has earned us exceptional customer loyalty.

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  • 2 Clinics with 80 beds
  • ICU with 12 beds with central online monitoring
  • Central Nursing station with telemetric monitoring data recording and data retrieval
  • Web linking of ICU with medical expert
  • Bio-Metric system for retrieval of data
  • Critical care unit is equipped with ADR monitoring and reporting
  • Recreational area for subjects
  • Walk in cold chambers at -200C
  • Defreezers at -700C for biological sample storage
  • In house GLP-Compliant bioanalytical laboratory with ultra modern equipment
  • ISO certified clinical laboratory accredited by NABL
  • More than 20,000 volunteer data base
  • Experience of conducting 1600 + BA/BE studies
  • More than 150 validated methods
  • SAS (Ver 9.4), Pharsight WinNonlin (Ver 6.4) software for bio statistics
  • Protocol design by qualified scientific team
  • Adoption of GLP & GCP guidelines as per regulatory requirements
  • Through QA check at every stage of study
  • Archival for clinical documents along with soft copies
  • PD/PK Studies
  • BA/BE Studies
  • Multi Dose and multi Period Studies
  • Steady state studies
  • Drug linearity
  • Drug-food Interaction Studies
  • Urinary drug elimination studies
  • Cosmetic and safety evaluation studies
  • Drug-Drug Interaction Studies
  • Phase I to Phase IV studies