- Our team includes experienced Physicians, Pharmacists, life science personnel and PV specialists, with a rich domain expertise to provide proficient services for clients.
- Rich experience in end-to-end Pharmacovigilance activities like case processing, signal detection and risk management, Scientific Literature monitoring, Medical information and call center services.
- Expertise in clinical trials, PK studies in patients, medical writing and clinical data management services.
- Expertise in project management, site management, medical affairs and regulatory affairs.
- Strong working relationship with GCP trained investigators and Board Certified Safety Physicians expert group with specialists across various therapeutic areas.
- Team members bring along combined experience of > 50 years.
- Robust QA process to ensure high-quality deliverables.
- Stringent training process in place to meet the highest standards of professional performance, and we strive to continuously improve our knowledge and services.
- Inspected by MHRA, USFDA, EMA, SUKL, MEB, INFRAMED, BfARM
- ISO Certified Companies – ISO 9001 – 2008
- The EU/US GMP certifications/ with leading EU Inspectorates are proud to announce 100% successful inspections in last 10 years
- EU GMP for first Vietnam sterile facility
- PV set up for largest Asian generic company with successful PV inspections by EU and US Authorities 2011 – 2016
- Dossier compilation for vaccines – obtaining MA via national and DCP registration as WEU within EU
- Complete set up of EU affiliate for Asian clients including registration of medicinal products, EU MAH, EU Distribution license within the challenging timeframe of 12 months
