OUR SERVICES · 01
CMC packages
From process knowledge to a coherent technical package.
Connect chemistry, manufacturing and controls into a practical plan for development, transfer and scale-up.
Discuss cmc packages ↗CMC planning & gap review
Map the manufacturing process, available evidence and outstanding technical questions. Agree priorities, responsibilities and the next development milestone.
- Development gap review
- CMC workplan and evidence map
- Technical risk and dependency register
Process development & transfer
Bring process knowledge, equipment requirements and receiving-site readiness into one transfer plan.
- Process and equipment gap assessment
- Technology-transfer planning
- Scale-up risks and acceptance criteria
Analytical & control strategy
Connect testing requirements to product and process understanding, including method development, transfer and lifecycle monitoring.
- Method development and transfer
- Specifications and in-process controls
- Stability and analytical evidence planning
Manufacturing documentation
Organise technical inputs into a consistent package for quality review and regulatory contribution.
- Manufacturing process descriptions
- Technical document review
- CMC document and submission input coordination
Start with a defined scope
Deliverables and specialist involvement are agreed around your product, development stage, site and market. Contact us to confirm the right support for your programme.
CONNECTED SUPPORT