Key Features

• Bio-equivalence/Bio-availability studies conducted since 1994 as per GCP and GLP standards
• Expertise available for Phase I, II and III clinical trials
• Round the clock operation of bioanalytical lab, equipped with 25 Mass Spectrometers at 3 Sites
• Independent Quality Assurance Unit: QA check at every stage of the clinical study
• 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

• CPUs with an overall capacity of 200 beds
• Facilities to conduct multiple BE studies simultaneously in two facilties
• (Hyderabad and Chennai) without any mixup of subjects or samples
• 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 7000 volunteers
• In-house screening and enrollment of study subjects
• Complete health check up including ECG
• Complete Hematology, Serum Chemistry, Urinalysis and Serology and as a part of pre-clinical and post-clinical evaluation. Screening also for Drugs of Abuse

Bio Analytical

Core competency in areas ranging from Method Development, Validation, Analysis, Application of Statistics and Report preparation using LCMS-MS, GCMS-MS, UPLC, HPLC

Types of studies

BE/BA studies conducted on various dosage forms: Tablets, capsules, extended release preparations, gels, jelly’s, solutions.etc for Pharmaceutical companies in India and Abroad.

• 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
• Cosmetic and safety evaluation studies

Services offered for Clinical Trials

• Project management
• Protocol preparation
• Adverse event reporting
• Data Management and Biostatistics
• Report preparation
• Central lab services - Bioanalytical and Pathology
• IEC services
• Preparation of CRFs

Regulatory Audits

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