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.
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.