Confidence Beyond Compliance

Our multidisciplinary team of experts is able to support you with risk management, risk evaluation and mitigation strategies. We can undertake the risk assessment for your product and the development and preparation of the Risk Management Plan, as well as support you in developing and implementing of additional risk minimization measures and with measuring the effectiveness of such measures. Our services include;

  • Risk mapping in the Pre-clinical or IND phases
  • Scenarios for focused clinical development and labeling
  • Strategies for implementing risk management
  • Phase III/IV Planning – special trials, labeling, surveillance
  • Development and management of pregnancy, product, adverse event, and disease registries
  • Development and evaluation of stakeholder education materials including focus groups and surveys
  • Assessment of REMS effectiveness

With experts in Europe and the United States, we are able to provide comprehensive global assistance.

Post authorisation pharmalex