CMC Hub
One searchable place to share Chemistry, Manufacturing, and Controls documents and past Q&A with health authorities worldwide.
The Challenge
The same CMC questions, again and again.
CMC questions from health authorities rarely arrive just once. The same questions about manufacturing processes, specifications, and controls come back from different agencies and different reviewers, and each time your team has to find the right documents, track down how it was answered before, and respond again.
How It Works
Let reviewers find the answer before they ask.
One hub for CMC documentation
Upload your CMC documents and your history of health authority questions and answers into a single, structured hub.
Searchable by health authority reviewers
Authorized health authority representatives can access the hub directly and search your shared CMC documentation and previous answers.
Questions checked against past answers
When a reviewer submits a question, they can see whether it has already been addressed. Questions that haven't been answered go straight to your team, so you spend your time on genuinely new questions.
Benefits
Spend your time on new questions.
- Fewer repeat questions for your CMC and regulatory teams
- Consistent answers across health authorities and markets
- A single, current source of CMC information for reviewers
CMC Hub by Feith is a standalone application, available separately from the Orbit platform.
See CMC Hub in action.
Let us show you how CMC Hub helps health authority reviewers find answers to CMC questions.
