• Studies conducted in SpinoS are in compliance with ICH-GCP and GLP
    • End to End service for Phase-I/ Bioequivalence studies
    • More than 300 bioanalytical methods developed and validated in house.
    • Round the clock Facility for management of any emergency, including:
      • AE monitoring and reporting with fully equipped ICU
      • Round the clock medical surveillance
      • Adequate stores of emergency medications and equipment
      • In-house Ambulance services
    • Clinics with 7 CPUS that have an overall capacity of 100 beds
    • Well Designed CPU’s to conduct mixed population studies at a same time.
    • Adequate and separate bathing and toilet facilities for both male and female subjects.
    • Separate recreational area for subjects.
    • In-house kitchen for preparation of Standard meals for subjects, along with adequate dining facilities.
    • Team has experienced in more than 100 ANDA submissions to FDA.
    • Central lab aggregated by NABL, located in house for screening of study subjects.
    • Separate facilities for recruiting and housing female volunteers.
    • Independent Quality Assurance Unit.
    • In house Archival area for the retention of the raw data and storage purpose.
    • Online monitoring and recording of the temperature for all the freezers.
  • Over all experience in conducting studies with 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