Major CMC changes
Through our experience with manufacturing sites, we can advise marketing authorisation holders and site personnel on the regulatory impact of complex changes, from analytical procedure and manufacturing process changes, to changes in suppliers and technology transfers between sites. We work with small molecules as well as biological products.
When supporting technology transfers we work together with manufacturing sites to ensure that all necessary regulatory activities related to the transfers are carried out. This ensures efficient and compliant transfer during scale-up and between different sites at production scale.
- Keeping a watchful eye on changing regulatory requirements, we notify clients when they might be affected and provide support
- Assist evaluation of change control procedures, considering regulatory impact and possible submission strategies
- Advise on variation classification and grouping
- Advise on documentation and studies required to support variations
- Provide expert comments to accompany variation applications
- Participate in cross-functional transfer teams and support the compilation of technical data packages and process mapping
- Provide technical consultancy on gap analysis at receiving sites
- Prepare and submit variation applications and manage regulatory procedures through to approval (see Product Lifecycle Management)