Regulatory Intelligence

PrimeVigilance has a robust Regulatory Intelligence (RI) process in place to ensure compliance worldwide, managed by a dedicated Regulatory Intelligence and Analytics Unit. Our experts are quality and compliance driven, with sole focus on timely and accurate regulatory intelligence delivery.

The company is ideally positioned with its independent RI system, built on extensive live experience and systematic data collection, and supported by an active network of parties involved to challenge, verify, and confirm information in real time.

Benefits of PrimeVigilance Regulatory Intelligence Services:

• Focus: Specialised Pharmacovigilance provider with an in-depth understanding of the entire product lifecycle.
• Optimisation: All-encompassing semi-automated process, designed for capturing changes in pharmacovigilance reporting requirements efficiently and accurately.​
• Expertise: Centralised team of SMEs supported by our CRO Ergomed and the largest global RA and PV Network skilled with interpretation, translation of local regulatory requirements and liaison with regulatory authorities​.
• Proactive compliance: Daily communication and established relationship with Regulatory Agencies, as well as diverse set of projects enable the collection of real-life data providing unparalleled depth and analysis of PV requirements.

Comprehensive Expertise Across Multiple Areas

Our global coverage includes surveillance for over 180 countries and territories across all pharmacovigilance, medical device vigilance and other relevant areas.​

Regulatory Intelligence system details requirements for:

• Clinical trials and post-marketing safety reporting (expedited and aggregate)​
• Compassionate use/expanded access​
• QPPV/LCPPV​
• PV System/PSMF​
• RMP​
• Signals​
• Literature screening
• Central Ethics Committees

Navigate the Complexities of the Pharmacovigilance Regulatory Landscape

PrimeVigilance regulatory intelligence services offer comprehensive and detailed insights into the ever-evolving landscape of the pharmacovigilance world, tailored to your global footprint and project needs. Our bespoke surveillance and impact analysis aim to determine implications of any new intelligence on your specific product portfolio.