• 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.
banner

Regulatory Services

Quest life sciences team provides independent regulatory services as an integral component of our services portfolio. Our regulatory affairs team helps the sponsors/client’s navigate complex regulatory requirements throughout the product’s development lifecycle. With in-depth knowledge of local regulatory procedures and effectiveliaisoning with local regulatory agencies ensures high efficiency in the Clinical Trial/BA-BE approval process.

Quest life sciences RA team provides the following :

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

  • Support on Indian regulatory environment & requirements.
  • Executing regulatory submissions (Protocols, Ethics committee documents & compiling dossiers.)
  • Preparation & submission of complete range of regulatory documents for obtaining:
    • Approval to conduct BA-BE studies/clinical trial in India.
    • Approval to import Test Drug.
    • Continuous follow-up post submission with regulatory authorities.
    • Renewal of Import license.

Quest life sciences has successfully completed over 22 audits from Indian & International regulatory agencies, 30+ sponsor audits from Indian and International clients and study submissions have been made to more than 8 countries.

Team QLS executes all the studies in strict compliance with regulatory and ICH GCP requirements.

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.