Phase-I/Bioequivalence (BE) studies

Key Features

• 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 26 Mass Spectrometers across 2 Sites, operational round the clock
• Over 200 bioanalytial 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 6 CPUS that have an overall capacity of 200 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

• Volunteer database of around 18000, that include healthy male and female, and post-menopausal women volunteers
• In-house clinical lab for screening of study subjects
• Separate facilities for recruitment and housing of female volunteers

Study Designs

Over 1000 BA/BE studies conducted so far on various dosage forms such as Tablets, capsules, extended release preparations, gels, jelly's, solutions, etc.

• Single dose, two period cross over studies
• Multiple dose, study state, cross over studies
• Single dose, multiple period cross over studies
• Food-interaction studies
• Drug-drug interaction studies
• Clinical end point studies
• PK studies in Patients

Regulatory Audit history

• US-FDA
• WHO
• BfArM, Germany
• Denmark
• France
• Portugal
• South Africa
• Sweden