Clinical Research

Phase-I/Bioequivalence (BE) studies

  • Studies conducted since 1994 in compliance with ICH-GCP and GLP

  • A full service CRO for Phase-I/ Bioequivalence studies

  • A large bioanalytical group, equipped with 25 Mass Spectrometers across 2 sites, operational round the clock

  • Over 300 bioanalytical methods developed and validated

  • Independent Quality Assurance Unit

  • Facility for emergency management of study subjects, including:

    • ADR monitoring and reporting with fully equipped ICU (8 beds)

    • Round the clock medical surveillance

    • Adequate stores of emergency medications and equipment

  • Clinic with 5 CPUS that have an overall capacity of 180 beds

  • Adequate bath and toilet facilities for study subjects

  • Separate recreational area for subjects

  • In-house kitchen for preparation of customized meals for subjects, along with adequate dining facilities

  • Supported more than 100 ANDA submissions to FDA

  • We are registered under US FDA's GDUFA Self-Identification requirements and Drug Firm Annual Registration

 
  • Volunteer database of approximately 26,000, including healthy male, female, and post-menopausal female volunteers

  • In-house clinical lab for screening of study subjects

  • Separate facilities for recruiting and housing female volunteers

 

Over 1800 BA/BE studies conducted so far on various dosage forms such as tablets, capsules, extended release preparations, gels, jellies, solutions, transdermal patches, injectables, etc.

  • Single dose, parallel, multiple (two/three/four) period cross over studies

  • Multiple dose, steady-state, cross over studies

  • Food-interaction studies

  • Drug-drug interaction studies

  • Clinical end point studies

  • PK studies in Patients

 
  • US-FDA

  • MHRA

  • WHO

  • BfArM, Germany

  • Afssaps, France

  • Denmark

  • Portugal

  • Sweden