• 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.
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Bio-Analytical Services

Quest Life sciences have more than a decade long experience in offering wide range of bio-analytical services with advanced facilities, equipments and trained personnel for custom method development, assay validation, and sample analysis using modern LC/MS/MS equipment to support the generic product development.

At Quest we have the the capability to handle various types of extraction procedures like liquid-liquid extractions, solid-phase extractions and pre-column | post-column derivatization procedures.

Our BA team has the complete and comprehensive knowledge of the specific regulatory requirements of international regulatory agencies such as FDA, EMEA, WHO, MCC, TGA etc.

Our method data bank has over 200+ new drug assays, with the standards set by international regulatory authorities and our team is continuously adding more validated methods to our data bank.

Method Development and Validation

All analytical methods developed and validated at Quest life sciences are compliant with latest national and international regulatory requirements. We develop, validate and conduct the clinical sample analysis in very cost effective and timely manner. Our highly sensitive machines allow us to develop bio-Analytical methods including routinely quantifying levels in pg/ml.

The BA team at Quest life sciences has developed highly sensitive and complex validated assays for multiple analytes, metabolites, prodrugs and light and temperature-sensitive compounds in various biological matrices e.g

  • Ampicillin sulbactam
  • Alendronate
  • Liposomal doxorubicin

The BA team expertise in Bio-Analytical methodologies and processes offres the fast and rapid sample processing throughput and quality data. As a Good Laboratory practice, the team at Quest life sciences perform bio analysis in line with international regulatory requirements with constant check from In Process Quality Control Team.

Infrastructure
Our Bioanalytical lab is equipped with the following :

  • 8 LC-MS/MS (SCIEX API 2000 (1), 3000(2), 4000(1), Thermo Vantage(2), Thermo Ultra (2)
  • 3 UFLC, 1 UHPLC, 3 HPLC.
  • 22,000 square-foot bio-analytical area.
  • Independent Sample Separation / prepration Area.
  • Solid Phase Extraction Systems (48 position SPE)
  • Nitrogen Evaporators – 02.
  • Refrigerated Centrifuge - 01
  • Deep Freezer (-20°C : 02) and (-70°C : 05 )
  • Automatic temperature recording device : 01 (12 Channel)
  • Independent server for LC/MS-MS.

All the equipments in BA lab use validated software that is CFR 21 Part 11 compliant. The Bio-Analytical data is from all the studies is comprehensively audited by the Quality Assurance and subjected to periodic in-house audits to ensure compliance.

All study samples at Quest life sciences are stored in secure freezers with temperatures ranging from - 20° C and -70° C. These freezers are monitored round the clock with power backup.

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.