BA/BE Studies

CEBIS USA is aware of your need for creative solutions to shorten the time it takes for your products to reach the market. Our staff is committed to working as a cohesive, committed team while adhering to all national and international quality standards.

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beds are available in our CPU
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square feet of clinic space
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committed personnel in Modern, two-bed intensive care unit
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deep freezers in Storage facility

We want to be the top clinical service provider, and we support ethical, safe research practices for bioequivalence and bioavailability investigations.

Our scientists and clinical investigators are skilled and experienced in conducting pharmacokinetic studies for INDs, NDAs, and ANDA filings. We offer our sponsors a comprehensive package, including protocol design, regulatory support, analytical quantification, pharmacokinetic, biostatistical and CSR compilation.

The CEBIS multidisciplinary team effectively coordinates between its internal and external stakeholders to ensure seamless and effective study execution. CEBIS has a state-of-the-art clinical site located in Ahmedabad India , with all necessary infrastructure and expertise for conduct of phase 1 studies., supporting IND/NDA/ANDA filings.

CEBIS volunteer database is robust including both male and female healthy volunteers that enables fast and efficient recruitment. In-house bioanalytical capabilities enable fast and accurate analysis of clinical samples.

A strong team of pharmacokinetic scientists, biostatistician subsequently derive data through validated software for compiling the final CSR to be used for regulatory filings.

An independent quality assurance team oversees all bioavailability and bioequivalence investigations at our facilities in accordance with all applicable national and international regulatory standards meeting CDSCO, ICH (E6), EMEA, ASEAN, US FDA, UK MHRA, NPRA (Malaysia), ANVISA (Brazil), guidelines.

We perform the following types of studies at CEBIS USA:

  • Single and multiple dose studies in fasting and fed conditions in healthy subjects
  • Drug-food and drug-drug interactions
  • Special | Patient Population (PK | PD) studies
  • Studies on the pharmacokinetics and pharmacodynamics of healthy volunteers.
  • Studies on postmenopausal healthy subjects.
  • Clinical endpoint BE patient population studies.

Our expertise with various formulations includes :

  • Solid Oral Formulations and modified released products.
  • Orally Dispersible Formulation.
  • Rectal creams and nasal sprays.
  • Liquid Syrups and Suspensions.
  • IM, IV, and subcutaneous parenteral.
  • Dermatological patches.

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7080, Southwest Fwy,
Houston, Texas – 77074