Pharmacovigilence Services

In current time for all the pharmaceutical companies there has been an increased focus on Drug Safety and Pharmacovigilance which involves much complicated regulatory requirements, means a complete and thorough knowledge is required to maintain compliance with world wide Drug Safety/Pharmacovigilance obligations. Our clinical knowledge and commercial understanding delivers a compliant, ethical and balanced approach to risk management.

Neo Regsol offers global Drug Safety/Pharmacovigilance service combined with specific consultancy and assistance throughout product development and marketing life cycle, to meet Pharmacovigilance needs of generic pharmaceutical industries.We have extensive knowledge in below activities specifically;

• Services of EU QPPV and country specific QPPV
• Case processing and Case/Safety Reporting
• Establishment of PSMF and drafting of Risk management plan
• Signal Detection
• Drafting and submission management of PSUR, PBRER, PADER, Clinical Overview and DSURs
• Comprehensive Pharmacovigilance Service Packages for the RoW Region
• Case search and sourcing
• Medical information Call Center