Risk Management

In the early phases of development of a new chemical entity, there is generally limited data available on the API, formulation approach and clinical profile (safety, half-life, dose etc) and so a generic approach to development is generally pursued until more relevant data becomes available.

RML Pharma Consulting can carry out an assessment on the CMC aspects of your asset:

  • Identify risks that could result in delays to your clinical program and/or require additional spends to address.

      • Design a program of work for you which oulines the steps required to mitigate these risks. We can also coordinate these activities at an appropriate contract facility if required.