Integrated Drug Development Solutions
Dosage Development
Dosage Development
Bioanalytical Development
Phase I–Phase IV
Bioanalytical
Project Development
Clinical trials-Phase i-iv
Bioavailability and Bioequivalence

We handle all types of bioavailability (BA)/ bioequivalence (BE) studies in healthy human male and female volunteers in accordance with International Conference on Harmonization (ICH)-Good Clinical Practice (GCP) guidelines.

Two clinics of 40 beds each are spread in 14,000 square feet area. Both the clinics seamlessly combine into a single 80 bed clinic for larger studies. With an extremely large female volunteer database of about 500 we currently conduct a large number of female studies. Our large female volunteer database with our unique facility design enables us to conduct mixed gender studies complying with global ethical standards. Our volunteer registration software is equipped with biometrics and is 21 CFR Part 11 compliant.

“Our on-site qualified pharmacists, formulation scientists and supporting Quality Assurance (QA) staff from our product development with the know-how, cGMP materials & qualified equipment are uniquely qualified in compounding your tough formulations right before the clinical study”

We conduct the following  studies for our partners  across the globe: :
  • Relative bioavailability
  • Absolute bioavailability
  • Multiple dose/Steady state studies
  • Dose escalating studies
  • Food & Drug interaction studies
  • Pharmacokinetic studies
  • Dispensing/Compounding pharmacy
Our dedicated QA team enables in ethical, efficient and compliant clinical research resulting in reliable outcomes.

Our capabilities includes:
  • Haematology
  • Biochemistry
  • Immunology / Serology
  • Urine analysis
  • Clinical pathology
  • Radiology

Accreditations: Our clinical laboratory was accredited by NABL (National Accreditation Board for Testing and Calibration Laboratories)


Compliments our boutique of clinical services

Our dedicated pharmacokinetics & biostatistics team provides statistical support using Win-Nonlin and Statistical Analysis System (SAS)with focus on your timelines and quality control.

Capabilities include:
  • Writing and documenting validated SAS programs for data analysis and reporting
  • Selection of appropriate statistical methods
  • Generation of randomization schedules
  • Defining analysis populations
  • Sample size rationale
  • Description of statistical methodology
  • Identifying outliers
  • In vitro- In vivo correlation (IVIVC)
Quality