• 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.

Quality Assurance and Compliance

Quest life sciences is a CRO where the quality and data integrity is accorded a prime importance. We the team at Quest life sciences are committed to high quality standards in all areas of our operations. All the projects and activities at QLS are conducted in accordance with local DCGI standards and international quality standards. Quest follows the best practices and ethical principles to ensure that our clients and regulatory authorities are provided the best possible services.

The Quality management systems at Quest life sciences are designed to comply with local & international quality standards. e.g. Principles of Good Clinical Practice and ICH guidelines which covers the following components :

  • Comprehensive Standard Operating Procedures (SOPs) detailing roles, responsibilities and duties of all personnel.
  • A detailed audit plan designed well in advance.
  • Maintaining quality at all levels.

QLS Quality Assurance (QA) department is an independent unit reporting to the President of the company. The main focus of QA team is to conduct the regular online audits during the conduct of studies, audit of post study activities and continual improvement of quality management system.

The well defined SOPs at QLS maintain quality standards and our quality management system requires that various operational teams follows the SOPs to ensure GCP/GLP Standards. The sponsors/clients regularly conduct audits of our quality management system either during the conduct of the study or post study completion. Involved at every step of the study conduct the QA team ensures that your projects receive the highest level of quality and this is achieved through regular conduct conduct of internal audits in all areas of our business.

Our QA team has in-house capabilities to perform:

  • Site Audits
  • Systems | Process Audits
  • Vendor Audits
  • Document Audits (Protocol, Clinical Study Reports & essential Clinical Trial documents)
  • GCP compliance review
  • IRB | EC audits
  • Drug accountability reviews
  • Study document reviews
  • Internal Audits for Area Specific SOP compliance

All our QA systems are compliant with all applicable local & international regulations.

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.