Quest Life Sciences understands your need for innovative solutions to accelerate your products time to market. Dedicated team working in harmony with complete adherence to quality standards are the trademark of our workforce.
We as a premier service provider of clinical services, believe in providing safe and ethical research solutions for Bioequivalence - Bioavailability studies.
Quest’s significant experience in carrying out a full range of bioavailability / bioequivalence studies has helped us to understand the complete generic development process. Our experience and expertise has given confidence to our sponsors that their project will be completed ethically, professionally and with most expeditious economic way possible. Our good infrastructure provides a quick accommodation of your project for male / female or special populations.
The bioavailability and bioequivalence studies are conducted at our facilities in strict compliance with national and international regulatory guidelines that are monitored by independent quality assurance team. Quest Life Sciences conducts BA/BE study as per CDSCO as well as ICH (E6)/ EMEA/ASEAN/US FDA/ UK MHRA/ Algeria etc. guidelines as desired by the sponsor. For conducting BA/BE study the protocol is prepared in consultation with the sponsor and clinical pharmacologist. The CDSCO approves the protocol and issues the NOC to conduct BA/BE study at a particular CRO which is mentioned in the protocol.The sponsor supplies the reference and test drugs, API and COA for method development along with the NOC from DCGI, New Delhi. The healthy human volunteers are accommodated in a air-conditioned CPU(Clinical Phamacological Unit) of Quest Life Sciences in MEPZ Tambaram, Chennai. The video-recording of informed consent process is carried out in presence of principal investigator, study co-ordinator, nurse, Phlebotomists/ CRA and other related staff prior to BA/BE study. The paramedics collects the blood samples from the volunteers as per the blood sampling points stated in the protocol and stored in a deep freezer at -70°C -20°C .
At Quest Life Sciences,we conduct the following type of studies :
Our expertise with various formulations includes but not limited to:
The volunteer recruitment team has created a good data base of +1500 healthy volunteers for the successful completion of the studies. Our volunteer management team utilize technology for mobilizing the study participants for your clinical studies. Comprehensive screening methodology has helped to create a data base of the following subjects :
Our clinical pharmacology unit (CPU) is equipped with: