REMS are regulatory safety documents (in the USA), addressing drug safety risks and potential mitigation strategies, in order to protect patient safety.
Similar in purpose to the European Risk Management Plan (RMP), REMS are complex documents required for all New Drug Applications (NDAs) covering the potential risks of the drug’s usage and the precautions to be enforced to manage these risks.
Trilogy has worked extensively on many major drug approvals documentation programmes, and provided a range of risk management plans covering a wide range of therapies and indications.
Our understanding of the crucial need to describe clearly the risks associated with medicines in the context of their benefits enables us to explain client’ messages clearly and consistently for the intended regulatory, healthcare, or patient audiences.
Trilogy can assist with the production of both the Proposed REMS document, as well as wtih the REMS supporting document.