Project Management

RML Pharma Consulting are experienced in the management of drug development projects and can successfully manage all of your CMC activities.

  • Manage all aspects of the outsourcing contracts with the outsourcing partner - this includes the initial preparation of the technical proposal for the contract as well as setting up both the service and confidentiality agreements.

      • Once the contract has been awarded, a kick-off meeting with the outsourcing partner will be held to outline the objectives and deliverables. Regular communication with the contractor (minimum weekly) continues up until the project has successfully delivered.

          • Interface with both internal functional leaders and external consultants to ensure that sufficient API is manufactured of the appropriate quality for the intended use (fit for purpose).

              • Negotiate realistic timelines with the wider project team for the supply of API

                  • Provide a project plan containing all of the activities required for delivery of the API - gives full visibility of progress against target and provides early warning of potential delays.

                      • Provide support for internal candidate selection documentation (or equivalent) relating to CMC activities.