CMC regulatory assessment
A review of the agreed quality information and the questions relevant to your programme.
Quality & technical documentation
Regulatory CMC support
Experienced chemistry, manufacturing and controls input to help you assess the regulatory implications of technical development and product change.
Make the connection between technical detail and regulatory decisions.
Quality information needs to support the product and its regulatory pathway. We bring specialist CMC experience to the assessment of your documentation, development questions and planned changes.
When we can help
- You need a regulatory assessment of CMC documentation.
- Technical development decisions need regulatory input.
- A manufacturing or quality change requires planning.
- You need specialist input into dossier preparation or authority responses.
What the support can include
The deliverables are agreed around your requirement. A typical scope may include:
Documentation and gap review
Focused input into the completeness and consistency of the relevant dossier material.
Change planning support
Assessment of the regulatory work associated with the agreed technical changes.
Specialist response input
CMC expertise to support the preparation and coordination of regulatory responses.
How we work with you
We establish the product type, development stage and question to be addressed. The relevant specialist reviews the agreed information and works with your technical and regulatory teams on the next actions.
Common questions
Can you provide a focused CMC review?
Yes. A defined review can be scoped around a particular document set, development decision or planned change.
Can your specialist work with our technical team?
Yes. We can agree the interfaces and responsibilities so CMC input supports the wider programme.
Who provides specialist CMC input?
Our CMC support draws on experienced regulatory specialists, some with over 40 years of regulatory experience.
Let’s move your programme forward.
Start with your regulatory question. We’ll discuss the relevant expertise and a practical scope.