Risk Evaluation and Management Programs
Specialized research and consultancy to manage and prevent the known or potential risks associated with medicine.

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Overview

We offer a range of services and extensive experience to support Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs) throughout the lifecycle. These include REMS analysis and evaluation, observational research, program and data management, medical communication, multi-sponsor program development, and more.

Key features

Scientific counselling, guidance & medical consultancy

Get help prior to FDA/EMA reviews, and around the communication of product safety and environmental risk issues.

30+ years of experience

We can help you meet all regulatory requirements for your product, using our vast resources in drug safety.

Regulatory acceptance

Our study protocols, including EURAS and INAS, are approved and recommended by international regulatory agencies.

Quality Standards

Learn more about our commitment to quality.
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Clinical Publications

Over 1,500 scientific and peer-reviewed articles to further understanding in health research.
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