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