The medical writers at Quest life sciences are professionals having strong academic background
having scientific experience in different therapeutic areas. The medical writing team helps to compile,
organize, write, edit and produce a wide range of medical and scientific documentation for BA/BE studies
and off site trials.
Our clients rely on our writers at any stage in their product development lifecycle – from clinical
development plan and investigator brochures to regulatory submission and approvals. Our medical writers
have expertise from PK/PD studies to phse trials.
The Medical Writers at Quest life sciences are proficient in:
- Clinical development plans
- Informed consent forms
- Clinical study reports
- Clinical sections of Common Technical Documents (eCTDs)
- Pre-FDA meeting briefing documents
- Preclinical study reports, expert reports and summaries
- Written and tabular summaries
- Method Validation Reports
- Bio analytical Reports
- ISR Reports
- Submission-ready Documentation (Hyperlinked eCTD formatting)
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.