Alava is focused on the selection and management of outsourced CMC operations as a core service. We will work with you to capture the substantial benefits of outsourcing, while reducing the associated costs and risks.
The overall CMC outsourcing process includes the following steps:
- Agree on the company’s development goals and strategy, taking into account timing and budget factors, and the company’s long-term vision.
- Develop a preliminary CMC project plan and budget and gain internal buy-in
- Identify the vendors with the best fit of capabilities
- Prepare RFPs to obtain clear agreement on project scope and deliverables, and identify gaps
- Review and followup of RFP responses, and reference checks
- Negotiate service agreements and quality agreements
- Manage the contracted activities, including regular project meetings and documentation of issues and decisions
Alava’s experience with the top CMC vendors and the outsourcing process will save time and get you to the best outcome with the lowest risk. Alava has the technical power and depth to help you outsource and manage challenging process and analytical development activities with confidence, as well as GMP activities.