There are clear advantages to having a dedicated CMC manager supporting your development project, such as:
- having guidance from preclinical and clinical development to the commercial stage
- securing qualified management of project on a daily or weekly basis
- assuring deliverables together with technical experts and other stakeholders
- having input to timelines to ensure that project deadlines are met.
Having the CMC manager as the point of contact to regulatory bodies, as well as communicating with other external parties (e.g. CMOs) can make your life much easier.
Why use our support with CMC project management?
Our consultants can be part of your organization and take over as the primary point of contact for a specific product, reducing your workload and helping you plan resources efficiently with potential to both expand and contract.
Arex Advisor can support regulatory CMC activities and submissions in all drug product phases.
Here are specific examples of work we do:
- manage and track technical documentation
- support product launches
- coordinate CMC/ Tech Ops teams
- regulatory impact assessments of CMC change controls
- elemental impurity assessments to fulfill ICH Q3D requirements
What is the result for you and your project?
Working closely together with you, we will be able to anticipate technical and regulatory issues and help you mitigate the risks. This should enable you take your project through development and submission to commercialization – without detours.