- 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
