VST helps clients proactively meet regulatory requirements throughout their product’s lifecycle. To meet increasingly complex and diverse global regulatory requirements, we have developed a comprehensive suite of services designed to ensure safety and expedite approvals. The entire process is monitored by licensed physicians who are trained to provide appropriate oversight and to analyse and evaluate the emerging safety profile of your compound.
Our experienced team members provide global safety processing and reporting services from database development to event reporting with complete documentation of the system validation and process implementation.
Our routine pharmacovigilance services include
- Set up and management of safety database
- Case processing including timely entry into and QC of the safety database
- Safety narrative writing
- Expedited safety reporting to regulatory authorities
- 24 hrs medical cover
- Signal Evaluation
- DSMB set up and support
- Scientific literature surveillance for signal detection as a part of routine PV activities
- SAE line listings
- Consistent and accurate coding of medical terms and MedDRA and WHODD
- Development Safety Update Reports
- Periodic Safety Update Reports / PBRERs