• Quest Life Sciences offers a full array of Clinical Trial Services,
  • Quest Life Sciences clears the Chile – ISP audit (Nov.7th – Nov.11th, 2016) without any major or minor observations.

BA | BE Studies

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 :

  • Single and multiple dose studies in fasting and fed conditions in healthy subjects
  • Drug-drug interaction, drug-food interaction
  • Various Routes of Administration
  • Special | Patient Population (PK | PD) studies
  • Bioequivalence / Bioavailability studies
  • Pharmacokinetic / Pharmacodynamic studies in Healthy subjects
  • Postmenopausal healthy / Patient Population studies.
  • Drug – Drug Interaction studies.
  • Proof of Concept studies
  • Protocol to Report
  • Project Management
  • Final submission Report (eCTD / ICH E3)
  • Clinical end point BE studies

Our expertise with various formulations includes but not limited to:

  • Solid Oral Formulations Tablets, Capsules, Soft Gels, Sprinkles, IR, ER, DR and SR.
  • Orally Dispersible Formulation.
  • Nasal and rectal spray.
  • Gums and Lozenges.
  • Opthalmics.
  • Liquid Formulations Suspensions & Syrups
  • Parenterals Intra Muscular, Intra Venous & Subcutaneous
  • Transdermal Patch.
  • Dermal Patches

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 :

  • Healthy Females with child-bearing potential
  • Elderly subjects
  • Hypogonadal males
  • Obese subjects

Our clinical pharmacology unit (CPU) is equipped with:

  • 80 beds arranged in two clinic study areas.
  • 22,000 square-foot clinic area
  • Four -bed Intensive Care Unit with continuous cardiac monitoring
  • 24/7 medical surveillance
  • Dedicated phlebotomists, nurses Doctor and para medical staff.
  • Refrigerated Centrifuges
  • -70°C deep frrezers storage facility

Fact Sheet

  • QLS incepted in year 2004 with a clear vision of offering services to accelerate clinical development of generics.
  • Pioneers in BA/BE and clinical phase trials.
  • Over 150 bio-analytical methods developed.
  • Over 22 successful Regulatory audits
  • Successful para IV submission done.
  • Strict adherence to quality and timelines.
  • Two clinical facilities in India
  • +30 National and International PharmaSponsor companies working with Quest.
  • US FDA, EMEA, Canada, Australia, Oman and WHO approvals.
  • Excellent volunteer database of patient population in various therapeutic areas.
  • A good and strong data base of post menopausal volunteers.