Consultancy & audits
Cellex Consulting
With several manufacturing licenses, over 100 audits carried out, successful support and submission of many clinical trials, and more than 50,000 cell collections – we are pleased to assist with our consulting expertise.
Guidelines and regulations about manufacturing and use of cell products
Do you have questions regarding the regulations, that must be followed when manufacturing, handling, and performing pre-clinical and clinical testing of cellular products? We are happy to assist you. You can rely on our expertise in the implementation of regulatory requirements such as EMA and FDA guidelines. We have acquired this expertise through the implementation of GMP and other GxP-compliant processes and the performance of gap analyses.
Advice on new technologies and genetic manipulation
Would you like to receive further information about molecular technologies? We would be happy to also advise you also on genetic manipulation, for example using viral vectors, and CRISPR/Cas9.
Audits & Consultancy
We are happy to support you with our experience. You can rely on our expertise in these areas:
- Audits of Aphereses Centers
- Manufacturing process design, scale-up
- Creation of a quality management system (SOPs)
- Writing of collection manuals (e.g., labelling)
- Planning and execution of clinical trials
Would you like to find out more about our consulting services? Please contact us.