About us
Our Mission
Committed towards delivering cost effective solutions for monitoring patient safety.
Our Values
Commitment towards quality driven outputs expertise in services tailored to meet client needs ensuring continuity of process development.
Our Vision
We provide a robust pharmacovigilance program which is US based quality oriented, cost-effective and scalable, ensuring prompt identification and timely analysis of safety issues and risks.
Our team comprises of seasoned experts from the industry who are medically qualified with vast experience in Pharmacovigilance consulting.
Our team comprises of US based Physicians, Pharmacists and Healthcare professionals.
Team Expertise
We specialize in developing processes related to safety monitoring during clinical development and post marketing surveillance. With our experts, you are guaranteed to receive high quality safety data with high chances for a successful NDA approval.
- High quality U.S. based medical review.
- Setting up processes for safety monitoring during clinical development.
- Aggregate reporting (DSURs, PSURs, PBRERs, PADERs).
- Signal evaluation and management.
- Experts available for filing NDA and building SOPs on signal detection, risk management & assessment.
- Expertise in developing SOPs for Pharmacovigilance processes and supporting post marketing commitment and post approval inspections by Health authorities.
- Providing complete training on every aspect of Pharmacovigilance.
- Medical information Contact Centre for handling medical inquires.
- Developing processes for early identification of risk and to propose mitigation strategies for investigational medicinal products.
- Drafting and updating risk management plans for post marketing compounds.