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.