Our knowledge in regulatory affairs, quality assurance and GMP will be a valuable asset in your technology transfer project.
You will gain by:
-Setting realistic timelines;
-Having a robust evaluation of the risks;
-Capturing the need for specific studies and documentation;
-Ensuring that the final process is manageable from both a practical and regulatory standpoint.
The timeline set for technology transfer processes is often optimistic, not taking account of unforeseen obstacles. This could put the entire process at significant risk. Therefore, it is particularly important to plan all the steps carefully, making sure that quality standards are met and that detours are avoided.
A technology transfer is usually a positive challenge. You may congratulate yourself if, for instance:
It is finally time to transfer the manufacturing of your medicinal product from pilot scale to production scale
You need to enhance the production capacity
A previously outsourced activity such as the analytical services of the QC lab will become in-house responsibility
Arex Advisor can help you:
-With gap analysis
-With risk assessment
-In planning your tech-transfer project
-Making sure that you have the complete documentation both for the product registration and authority inspection.
Our experts have extensive experience in this and have been involved in technology transfer of analytical methods/processes as well as manufacturing processes.
Acting Qualified Person (QP)
Auditing
Commercial production support and advice
GMP responsibilities for MA holders
Quality assurance and GMP compliance
Quality control and batch evaluation
Nelly Fransén
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.
